Surgical Fastener Applying Apparatus

ABSTRACT

The present disclosure relates to surgical fastener applying apparatus for sequentially applying a plurality of surgical fasteners to body tissue. The surgical fastener applying apparatus includes a replaceable cartridge assembly receivable in a distal end portion of a cartridge receiving half-section, the cartridge assembly including a safety lockout pivotably disposed along the upper surface of the cartridge assembly and movable from an unlocked orientation permitting assembly of an anvil half-section to the cartridge receiving half-section, to a locked orientation preventing assembly of the anvil half-section to the cartridge receiving-half section.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation Application claiming thebenefit of and priority to U.S. patent application Ser. No. 12/619,829,filed on Nov. 17, 2009, which is a Continuation Application claiming thebenefit of and priority to U.S. patent application Ser. No. 12/115,612,filed on May 6, 2008, now U.S. Pat. No. 7,631,794, which is aContinuation Application claiming the benefit of and priority to U.S.patent application Ser. No. 11/699,686, filed on Jan. 29, 2007, now U.S.Pat. No. 7,631,793, which is a Continuation Application claiming thebenefit of and priority to U.S. patent application Ser. No. 10/508,191,filed on Apr. 22, 2005, now U.S. Pat. No. 7,334,717, which is a 35U.S.C. §371 National Filing of International Application Serial No.PCT/US03/08342, filed on Mar. 19, 2003, which, in turn, claims thebenefit of and priority to U.S. Provisional Application Ser. No.60/356,761, filed on Mar. 19, 2002 and U.S. Provisional Application Ser.No. 60/416,371, filed on Oct. 4, 2002, the entire contents of each ofwhich being incorporated herein by reference.

U.S. patent application Ser. No. 10/508,191, filed on Apr. 22, 2005, isalso a Continuation-in-Part Application claiming the benefit of andpriority to U.S. patent application Ser. No. 10/490,517, filed on Mar.23, 2004, now U.S. Pat. No. 7,032,799, which is a 35 U.S.C. §371National Filing of International Application Serial No. PCT/US02/31963,filed on Oct. 4, 2002, which, in turn, claims the benefit of andpriority to U.S. Provisional Application Ser. No. 60/327,369, filed onOct. 5, 2001, the benefit of which is claimed herein, and the entirecontents of each of which being incorporated herein by reference.

U.S. patent application Ser. No. 12/619,829, filed on Nov. 17, 2009, isalso a Continuation-in-Part Application claiming the benefit of andpriority to U.S. patent application Ser. No. 12/186,269, filed on Aug.5, 2008, now U.S. Pat. No. 7,721,933, which is a ContinuationApplication claiming the benefit of and priority to U.S. patentapplication Ser. No. 12/011,419, filed on Jan. 24, 2008, now U.S. Pat.No. 7,568,604, which is a Continuation Application claiming the benefitof and priority to U.S. patent application Ser. No. 11/699,620, filed onJan. 29, 2007, now U.S. Pat. No. 7,419,081, which is a ContinuationApplication claiming the benefit of and priority to U.S. patentapplication Ser. No. 11/356,912, filed on Feb. 16, 2006, now U.S. Pat.No. 7,293,685, which is a Divisional Application claiming the benefit ofand priority to U.S. patent application Ser. No. 11/292,736, filed onDec. 2, 2005, now U.S. Pat. No. 7,140,527, which is a DivisionalApplication claiming the benefit of and priority to U.S. patentapplication Ser. No. 10/399,071, filed on Apr. 10, 2003, now U.S. Pat.No. 7,055,730, which is a 35 U.S.C. §371 National Filing ofInternational Application No. PCT/US01/32213, filed Oct. 15, 2001, whichclaims the benefit of and priority to U.S. Provisional Application Ser.No. 60/240,461, filed on Oct. 13, 2000, the entire contents of each ofwhich being incorporated herein by this reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical fastener applying apparatusand, more particularly, to surgical fastener applying apparatus forapplying a plurality of surgical fasteners to body tissue.

2. Discussion of Related Art

Surgical apparatus or instruments, wherein tissue is first grasped orclamped between opposing jaw structures and then joined by means ofsurgical fasteners are well known in the art. In some such instruments aknife is provided to cut the tissue which has been joined by thefasteners. The fasteners are typically in the form of surgical staples,although, other surgical fasteners may also be utilized, such as, forexample, clips or two part polymeric surgical fasteners.

Instruments for applying surgical fasteners typically include twoelongated beam members which are respectively used to capture or clamptissue therebetween. Typically, one of the beam members carries adisposable cartridge assembly which houses a plurality of staplesarranged in at least two lateral rows, while the other beam memberincludes an anvil which defines a surface for forming the staple legs asthe staples are driven from the cartridge assembly. Where two partfasteners are used, this beam member typically carries the mating part,e.g. the receiver, to the fasteners driven from the cartridge assembly.Generally, the staple formation process is affected by the interactionbetween one or more longitudinally moving camming members and a seriesof individual staple pushers. As the camming members travellongitudinally through the cartridge carrying beam member, theindividual pusher members are biased laterally, thus acting upon thestaples to sequentially eject the staples from the cartridge. A knifemay travel with the camming members or the individual pusher membersbetween the staple rows to cut the tissue between the rows of formedstaples. Examples of such instruments are disclosed in U.S. Pat. No.3,079,606 and U.S. Pat. No. 3,490,675, each of which is incorporatedherein in its entirety by reference.

A later surgical apparatus or instrument, disclosed in U.S. Pat. No.3,499,591, incorporated herein in its entirety by reference, applies adouble row of staples on each side of the incision. This is accomplishedby providing a cartridge assembly in which at least one camming membermoves through an elongate guide path between two sets of staggeredstaple carrying grooves. Staple pushers are located within the groovesand are positioned in such a manner so as to be contacted by thelongitudinally moving camming member to effect ejection of the staples.

A need exists for improved surgical fastener applying apparatus, and forimproved mechanisms and methods for producing improved surgical fastenerapplying apparatus.

SUMMARY

The present disclosure relates to surgical fastener applying apparatusfor sequentially applying a plurality of surgical fasteners to bodytissue.

According to one aspect of the present disclosure, a surgical fastenerapplying apparatus is disclosed including an anvil half-section having aproximal end portion and a distal end portion including an anvil whichdefines a fastener forming surface against which surgical fasteners aredriven; a cartridge receiving half-section having a proximal end portionand a distal end portion, the cartridge receiving half-section beingconfigured and adapted to releasably mate with the anvil half-section,the surgical fastener applying apparatus having an assembledconfiguration wherein the anvil half-section and the cartridge receivinghalf-section are positioned in juxtaposed alignment with each other, theanvil half-section and the cartridge receiving half-section beingrelatively movable from an unclamped position to a fully clampedposition to clamp tissue therebetween, the cartridge half-sectionincluding a pivotable clamping lever, wherein movement of the clampinglever from a first position to a second position moves the cartridgereceiving and anvil half-sections to the fully clamped position; and areplaceable cartridge assembly receivable in the distal end portion ofthe cartridge receiving half-section. The cartridge assembly includes anupper surface and a plurality of surgical staples and surgical staplepushers, the surgical staples being ejectable by the pusher members fromthe cartridge assembly through openings in the upper surface, thecartridge assembly defining at least one slot for receiving at least oneknife therein, the cartridge assembly including a safety lockoutpivotably disposed along the upper surface of the cartridge assembly andmovable from an unlocked orientation permitting assembly of the anvilhalf-section, to the cartridge receiving half-section to a lockedorientation preventing assembly of the anvil half-section to thecartridge receiving-half section.

In one embodiment, the safety lockout is biased from the unlockedorientation to the locked orientation. Preferably, the safety lockout isbiased by a spring. It is envisioned that the safety lockout includes atransverse horizontal surface formed on the underside thereof and whichis configured and adapted to engage a member formed on a surface of theat least one knife. The transverse horizontal surface and the member ofthe at least one knife are configured and dimensioned such that when theat least one knife is displaced in a distal direction, the member of theat least one knife disengages from the transverse horizontal surface. Itis envisioned that the member of the at least one knife is a hook.

In another embodiment, the cartridge receiving half-section includes aloading and lockout mechanism operatively associated therewith, theloading and lockout mechanism being configured and adapted to facilitateloading of the cartridge assembly to the to the cartridge receivinghalf-section and to prevent firing of the surgical fastener applyingapparatus until the cartridge assembly is properly assembled withcartridge receiving half-section. It is envisioned that the loading andlockout mechanism includes a rocker pivotably mounted to the cartridgereceiving half-section, the rocker having a locked-out position whichprevents firing of the surgical fastener applying apparatus and a firingposition which permits tiring of the surgical fastener applyingapparatus, the rocker defining a downwardly extending blocking surfacewhich, when in the locked-out position, the rocker engages a cam bar andprevents displacement of the cam bar in a distal direction and when inthe firing position the rocker disengages the cam bar and allows the cambar to be displaced distally.

It is envisioned that the rocker defines an upper edge blocking surface,wherein when the rocker is in the locked-out position the upper edgeblocking surface engages a knife actuating bar and prevents displacementof the knife actuating bar in a distal direction, and when the rocker isin the firing position the upper edge blocking surface disengages theknife actuating bar and allows the knife actuating bar to be displaceddistally. The rocker is preferably biased to the locked-out position.The rocker is preferably adapted to be pivoted to the firing positionwhen the anvil half-section is coupled to the cartridge receivinghalf-section.

In yet another embodiment, the surgical fastener applying apparatusfurther includes a gap adjustment mechanism operatively associatedbetween the anvil half-section and the cartridge receiving half-section,wherein the gap adjustment mechanism is configured and adapted to varythe size of a gap between the distal end portions of the anvilhalf-section and the cartridge receiving half-section. It is envisionedthat the gap adjustment mechanism includes a cam positioned between theanvil half-section and the cartridge receiving half-section when in theassembled condition, wherein manipulation of the cam results in thevariation of the size of the gap between the distal ends of the anvilhalf-section and the cartridge receiving half-section.

Preferably, the cam includes a forward portion, a body portion and arearward portion, wherein the body portion of the cam defines a centralrotational axis and wherein the forward and rearward portions share acommon axis which is spaced a distance from the central rotational axis.It is envisioned that body portion is rotationally disposed withinapertures formed in the anvil half section and the forward and rearwardportions rest against respective surfaces of opposed hinge platesextending from the cartridge receiving half-section, wherein rotation ofthe cam about the central rotational axis results in the forward andrearward portions of the cam to displace the cartridge receivinghalf-section.

It is envisioned that the gap adjustment mechanism includes a cam lockconfigured and adapted to engage the body portion of the cam and toprevent rotation of the cam after adjustment of the gap.

In another embodiment, the clamping lever includes a body portion havinga pair of juxtaposed hinge plates each defining an access channel formedtherein, each access channel being is configured and dimensioned toreceive a respective mounting boss extending laterally from the anvilhalf-section, such that as the clamping lever is approximated toward thecartridge receiving half-section, the access channels guide the mountingbosses therethrough to properly assemble the anvil half-section with thecartridge receiving half-section.

Preferably, when the anvil receiving half-section is oriented in thehorizontal plane and the clamping lever is in the first position, theopening to each access channel can be vertically accessed. It isenvisioned that each access channel is generally orthogonal to thecartridge receiving half-section. It is further envisioned that eachaccess channel faces angularly relative to the cartridge receivinghalf-section.

In yet another embodiment, the proximal end of the cartridge receivinghalf-section includes a pair of upstanding juxtaposed pivot plates eachincluding a pin receiving slot formed therein. The proximal end of theanvil half-section includes a pin extending laterally from either sidethereof, the pin being positionable within the pin receiving slotsformed in the pivot plates of the cartridge receiving half-section. Thepin preferably extends laterally from the proximal end of the anvilhalf-section is non-round in cross-section, and wherein the shape of thepin cooperates with the pin receiving slot to limit the angle at whichthe anvil half-section can be approximated to the cartridge receivinghalf-section in order to effectuate proper assembly. It is envisionedthat the angle is less than about 15°. Preferably, the pin has a pearshape cross-section defined by a larger lower portion and a smallerupper portion.

In another embodiment, the surgical fastener applying apparatus includesa firing slide operatively associated with the cartridge receivinghalf-section, the firing slide including a firing lever pivotablycoupled thereto, wherein the firing lever is adapted to enable thesurgical fastener applying apparatus to be fired from either sidethereof. The firing slide includes, in one embodiment, a pair of cambars configured and adapted to sequentially expel the plurality offasteners in a direction transverse to the direction of movement of thepair of cam bars, and a knife actuating bar positioned between the pairof cam bars for displacing the knife in the direction of movement of thecam bars.

The firing slide includes, in another embodiment, a slide block having ahub extending therefrom for receipt in a pivot hole formed in the firinglever; and a pedal having a pin reciprocally received in and extendingfrom a hole formed in the slide block, such that as the firing slide isdisplaced in a distal direction the pin from the pedal extends into arecess formed in the firing lever to thereby prevent the firing leverfrom thereafter pivoting about the hub of the slide block.

In another aspect of the present disclosure, a surgical fastenerapplying apparatus is disclosed including an anvil half-section; acartridge receiving half-section configured and adapted to releasablymate with the anvil half-section; and a gap adjustment mechanismoperatively associated between the anvil half-section and the cartridgereceiving half-section, wherein the gap adjustment mechanism isconfigured and adapted to vary the size of the gap between the distalend portions of the anvil half-section and the cartridge receivinghalf-section.

In one embodiment, the gap adjustment mechanism includes a campositioned between the anvil half-section and the cartridge receivinghalf-section when in the assembled condition, wherein manipulation ofthe cam results in the variation of the size of the gap between thedistal ends of the anvil half-section and the cartridge receivinghalf-section. It is envisioned that the cam includes a forward portion,a body portion and a rearward portion, wherein the body portion of thecam defines a central rotational axis and wherein the forward andrearward portions share a common axis which is spaced a distance fromthe central rotational axis. The body portion is rotationally disposedwithin apertures formed in the anvil half section and the forward andrearward portions rest against respective surfaces of opposed hingeplates extending from the cartridge receiving half-section, whereinrotation of the cam about the central rotational axis results in theforward and rearward portions of the cam to displace the cartridgereceiving half-section.

It is envisioned that the gap adjustment mechanism includes a cam lockconfigured and adapted to engage the body portion of the cam and toprevent rotation of the cam after adjustment of the gap.

In another embodiment, the cartridge receiving half-section includes aloading and lockout mechanism operatively associated therewith, theloading and lockout mechanism being configured and adapted to facilitateloading of the cartridge assembly to the to the cartridge receivinghalf-section and to prevent firing of the surgical fastener applyingapparatus until the cartridge assembly is properly loaded onto cartridgereceiving half-section. The loading and lockout mechanism includes arocker pivotably mounted to the cartridge receiving half-section, therocker having a locked-out position which prevents firing of thesurgical fastener applying apparatus and a firing position which permitsfiring of the surgical fastener applying apparatus, when in thelocked-out position, the rocker engages a cam bar and preventsdisplacement of the cam bar in a distal direction and when in the firingposition the rocker disengages the cam bar and allows the cam bar to bedisplaced distally.

It is envisioned that the rocker defines an upper edge blocking surface,wherein when the rocker is in the locked-out position the upper edgeblocking surface engages a knife actuating bar and prevents displacementof the knife actuating bar in a distal direction and when the rocker isin the firing position the upper edge blocking surface disengages theknife actuating bar and allows the knife actuating bar to be displaceddistally. Preferably, the rocker is biased to the locked-out position.It is contemplated that the rocker is pivoted to the firing positionwhen the anvil half-section is coupled to the cartridge receivinghalf-section.

In another embodiment, the clamping lever includes a body portion havinga pair of juxtaposed hinge plates each defining an access channel formedtherein, wherein each access channel is configured and dimensioned toreceive a respective mounting boss extending laterally from the anvilhalf-section, wherein as the clamping lever is approximated toward thecartridge receiving half-section, the access channels guide the mountingbosses therethrough to properly mate the anvil half-section with thecartridge receiving half-section.

Preferably, when the anvil receiving half-section is oriented in thehorizontal plane and the clamping lever is in the first position, theopening to each access channel can be vertically accessed. It isenvisioned that each access channel is generally orthogonal to thecartridge receiving half-section. It is further envisioned that eachaccess channel faces angularly relative to the cartridge receivinghalf-section.

In another embodiment, the proximal end of the cartridge receivinghalf-section includes a pair of upstanding juxtaposed pivot plates eachincluding a pin receiving slot formed therein. The proximal end of theanvil half-section includes a pin extending laterally from either sidethereof, wherein the pin at the proximal end of the anvil half-sectionis positionable within the pin receiving slots formed in the pivotplates of the cartridge receiving half-section.

The pin extending laterally from the proximal end of the anvilhalf-section is non-round, and wherein the pin limits the angle at whichthe anvil half-section can be approximated to the cartridge receivinghalf-section in order to effectuate proper assembly. Preferably, theangle is less than about 15°. It is envisioned that the pin has a pearshape cross-section defined by a larger lower portion and a smallerupper portion.

In another embodiment, the surgical fastener applying apparatus includesa firing slide operatively associated with the cartridge receivinghalf-section, the firing slide including a firing lever pivotablycoupled thereto, wherein the firing lever enables the surgical fastenerapplying apparatus to be fired from either side thereof. It isenvisioned that the firing slide includes, in one embodiment, a pair ofcam bars configured and adapted to sequentially expel the plurality offasteners in a direction transverse to the direction of movement of thepair of cam bars, a knife actuating bar positioned between the pair ofcam bars for displacing the knife in the direction of movement of thecam bars.

It is envisioned that the firing slide includes, in another embodiment,a slide block having a hub extending therefrom for receipt in a pivothole formed in the firing lever, and a pedal having a pin reciprocallyreceived in a hole formed in the slide block, wherein as the firingslide is displaced in a distal direction the pin from the pedal extendsinto a recess formed in the firing lever to thereby prevent the firinglever from thereafter pivoting about the hub of the slide block.

According to another aspect of the present disclosure, a surgicalfastener applying apparatus is disclosed which includes an anvilhalf-section; and a cartridge receiving half-section configured andadapted to releasably mate with the anvil half-section, wherein thecartridge receiving half-section includes a loading and lockoutmechanism operatively associated therewith, the loading and lockoutmechanism being configured and adapted to facilitate loading of thecartridge assembly to the to the cartridge receiving half-section and toprevent firing of the surgical fastener applying apparatus until thecartridge assembly is properly loaded onto cartridge receivinghalf-section.

It is envisioned that the loading and lockout mechanism includes arocker pivotably mounted to the cartridge receiving half-section, therocker having a locked-out position which prevents firing of thesurgical fastener applying apparatus and a firing position which permitsfiring of the surgical fastener applying apparatus, when in thelocked-out position, the rocker engages a cam bar and preventsdisplacement of the cam bar in a distal direction and when in the firingposition the rocker disengages the cam bar and allows the cam bar to bedisplaced distally.

The rocker defines an upper edge blocking surface, wherein when therocker is in the locked-out position the upper edge blocking surfaceengages a knife actuating bar and prevents displacement of the knifeactuating bar in a distal direction and when the rocker is in the firingposition the upper edge blocking surface disengages the knife actuatingbar and allows the knife actuating bar to be displaced distally. It isenvisioned that the rocker is biased to the locked-out position.Preferably, the rocker is pivoted to the firing position when the anvilhalf-section is coupled to the cartridge receiving half-section.

It is envisioned that the clamping lever includes a body portion havinga pair of juxtaposed hinge plates each defining an access channel formedtherein, wherein each access channel is configured and dimensioned toreceive a respective mounting boss extending laterally from the anvilhalf-section, wherein as the clamping lever is approximated toward thecartridge receiving half-section, the access channels guide the mountingbosses therethrough to properly mate the anvil half-section with thecartridge receiving half-section.

Preferably, when the anvil receiving half-section is oriented in thehorizontal plane and the clamping lever is in the first position, theopening to each access channel can be vertically accessed. It isenvisioned that each access channel is generally orthogonal to thecartridge receiving half-section. It is further envisioned that eachaccess channel faces angularly relative to the cartridge receivinghalf-section.

In another embodiment, the proximal end of the cartridge receivinghalf-section includes a pair of upstanding juxtaposed pivot plates eachincluding a pin receiving slot formed therein. The proximal end of theanvil half-section includes a pin extending laterally from either sidethereof, and wherein the pin at the proximal end of the anvilhalf-section is positionable within the pin receiving slots formed inthe pivot plates of the cartridge receiving half-section.

It is envisioned that the pin extending laterally from the proximal endof the anvil half-section is non-round, wherein the pin limits the angleat which the anvil half-section can be approximated to the cartridgereceiving half-section in order to effectuate proper assembly.Preferably, the angle is less than about 15°. It is envisioned that thepin has a pear shape cross-section defined by a larger lower portion anda smaller upper portion.

In another embodiment, the surgical fastener applying apparatus includesa firing slide operatively associated with the cartridge receivinghalf-section, the firing slide including a firing lever pivotablycoupled thereto, wherein the firing lever enables the surgical fastenerapplying apparatus to be fired from either side thereof.

The firing slide includes, in one embodiment, a pair of cam barsconfigured and adapted to sequentially expel the plurality of fastenersin a direction transverse to the direction of movement of the pair ofcam bars, a knife actuating bar positioned between the pair of cam barsfor displacing the knife in the direction of movement of the cam bars.

The firing slide includes, in another embodiment, a slide block having ahub extending therefrom for receipt in a pivot hole formed in the firinglever; and a pedal having a pin reciprocally received in a hole formedin the slide block, wherein as the firing slide is displaced in a distaldirection the pin from the pedal extends into a recess formed in thefiring lever to thereby prevent the firing lever from thereafterpivoting about the hub of the slide block.

It is envisioned that the surgical fastener applying apparatus furtherincludes a replaceable cartridge assembly receivable in the distal endportion of the cartridge receiving half-section, the cartridge assemblyhaving an upper surface and a plurality of surgical staples and surgicalstaple pushers, the surgical staples being ejectable by the pushermembers from the cartridge assembly through openings in the uppersurface, the cartridge assembly defining at least one slot for receivingat least one knife therein, the cartridge assembly including a safetylockout pivotably disposed along the upper surface of cartridge assemblyand movable from an unlocked orientation permitting assembly of theanvil half-section to the cartridge receiving half-section to a lockedorientation preventing assembly of the anvil half-section to thecartridge receiving-half section.

The safety lockout is biased from the unlocked orientation to the lockedorientation. Preferably, the safety lockout is biased by a spring. Thesafety lockout includes a transverse horizontal surface formed on theunderside thereof which transverse horizontal surface is configured andadapted to engage a hook formed on an upper surface of the at least oneknife. The transverse horizontal surface and the hook are configured anddimensioned such that when the at least one knife is displaced in adistal direction, the hook disengages from the transverse horizontalsurface.

In yet another aspect of the present disclosure, a surgical fastenerapplying apparatus is disclosed which includes an anvil half-section;and a cartridge receiving half-section configured and adapted toreleasably mate with the anvil half-section, the cartridge half-sectionincluding a pivotable clamping lever, wherein movement of the clampinglever from a first position to a second position moves the cartridgereceiving and anvil half-sections to the fully clamped position, andwherein the clamping lever includes a body portion having a pair ofjuxtaposed hinge plates each defining an access channel formed therein,wherein each access channel is configured and dimensioned to receive arespective mounting boss extending laterally from the anvilhalf-section, wherein as the clamping lever is approximated toward thecartridge receiving half-section, the access channels guide the mountingbosses therethrough to properly mate the anvil half-section with thecartridge receiving half-section.

Preferably, when the anvil receiving half-section is oriented in thehorizontal plane and the clamping lever is in the first position, theopening to each access channel can be vertically accessed. It isenvisioned that each access channel is generally orthogonal to thecartridge receiving half-section. It is further envisioned that eachaccess channel faces angularly relative to the cartridge receivinghalf-section.

It is envisioned that the proximal end of the cartridge receivinghalf-section includes a pair of upstanding juxtaposed pivot plates eachincluding a pin receiving slot formed therein. The proximal end of theanvil half-section includes a pin extending laterally from either sidethereof, and wherein the pin at the proximal end of the anvilhalf-section is positionable within the pin receiving slots formed inthe pivot plates of the cartridge receiving half-section. The pinpreferably extends laterally from the proximal end of the anvilhalf-section is non-round, wherein the pin limits the angle at which theanvil half-section can be approximated to the cartridge receivinghalf-section in order to effectuate proper assembly. It is envisionedthat the angle is less than about 15°. Preferably, the pin has a pearshape cross-section defined by a larger lower portion and a smallerupper portion.

It is further envisioned that the surgical fastener applying apparatusincludes a firing slide operatively associated with the cartridgereceiving half-section, the firing slide including a firing leverpivotably coupled thereto, wherein the firing lever enables the surgicalfastener applying apparatus to be fired from either side thereof.

It is contemplated that the firing slide includes, in one embodiment, apair of cam bars configured and adapted to sequentially expel theplurality of fasteners in a direction transverse to the direction ofmovement of the pair of cam bars, a knife actuating bar positionedbetween the pair of cam bars for displacing the knife in the directionof movement of the cam bars.

It is further contemplated that the firing slide includes, in anotherembodiment, a slide block having a hub extending therefrom for receiptin a pivot hole formed in the firing lever; and a pedal having a pinreciprocally received in a hole formed in the slide block, wherein asthe firing slide is displaced in a distal direction the pin from thepedal extends into a recess formed in the firing lever to therebyprevent the firing lever from thereafter pivoting about the hub of theslide block.

It is envisioned that the surgical fastener applying apparatus includesa replaceable cartridge assembly receivable in the distal end portion ofthe cartridge receiving half-section, the cartridge assembly having anupper surface and a plurality of surgical staples abutting surgicalstaple pushers, the surgical staples being ejectable from the cartridgeassembly through openings in the upper surface, the cartridge assemblydefining at least one slot for receiving at least one knife therein, thecartridge assembly including a safety lockout pivotably disposed alongthe upper surface of cartridge assembly and movable from an unlockedorientation permitting assembly of the anvil half-section to thecartridge receiving half-section to a locked orientation preventingassembly of the anvil half-section to the cartridge receiving-halfsection.

The safety lockout is biased from the unlocked orientation to the lockedorientation. Preferably, the safety lockout is biased by a spring. Thesafety lockout includes a transverse horizontal surface formed on theunderside thereof which transverse horizontal surface is configured andadapted to engage a hook formed on an upper surface of the at least oneknife. It is envisioned that the transverse horizontal surface and thehook are configured and dimensioned such that when the at least oneknife is displaced in a distal direction, the hook disengages from thetransverse horizontal surface.

It is envisioned that the surgical fastener applying apparatus furtherincludes a replaceable cartridge assembly receivable in the distal endportion of the cartridge receiving half-section, the cartridge assemblyhaving an upper surface and a plurality of surgical staples and surgicalstaple pushers, the surgical staples being ejectable by the pushermembers from the cartridge assembly through openings in the uppersurface, the cartridge assembly defining at least one slot for receivingat least one knife therein, the cartridge assembly including a safetylockout pivotably disposed along the upper surface of the cartridgeassembly and movable from an unlocked orientation permitting assembly ofthe anvil half-section, to the cartridge receiving half-section to alocked orientation preventing assembly of the anvil half-section to thecartridge receiving-half section.

It is envisioned that the cartridge receiving half-section includes aloading and lockout mechanism operatively associated therewith, theloading and lockout mechanism being configured and adapted to facilitateloading of the cartridge assembly to the to the cartridge receivinghalf-section and to prevent firing of the surgical fastener applyingapparatus until the cartridge assembly is properly loaded onto cartridgereceiving half-section.

The loading and lockout mechanism includes a rocker pivotably mounted tothe cartridge receiving half-section, the rocker having a locked-outposition which prevents firing of the surgical fastener applyingapparatus and a firing position which permits firing of the surgicalfastener applying apparatus, when in the locked-out position, the rockerengages a cam bar and prevents displacement of the cam bar in a distaldirection and when in the firing position the rocker disengages the cambar and allows the cam bar to be displaced distally. The rocker definesan upper edge blocking surface, wherein when the rocker is in thelocked-out position the upper edge blocking surface engages a knifeactuating bar and prevents displacement of the knife actuating bar in adistal direction and when the rocker is in the firing position the upperedge blocking surface disengages the knife actuating bar and allows theknife actuating bar to be displaced distally. Preferably, the rocker isbiased to the locked-out position. The rocker is pivoted to the firingposition when the anvil half-section is coupled to the cartridgereceiving half-section.

It is envisioned that surgical fastener applying apparatus furtherincludes a gap adjustment mechanism operatively associated between theanvil half-section and the cartridge receiving half-section, wherein thegap adjustment mechanism is configured and adapted to vary the size of agap between the distal end portions of the anvil half-section and thecartridge receiving half-section.

The gap adjustment mechanism includes a cam positioned between the anvilhalf-section and the cartridge receiving half-section when in the matedcondition, wherein manipulation of the cam results in the variation ofthe size of the gap between the distal ends of the anvil half-sectionand the cartridge receiving half-section. It is envisioned that the camincludes a forward portion, a body portion and a rearward portion,wherein the body portion of the cam defines a central rotational axisand wherein the forward and rearward portions share a common axis whichis spaced a distance from the central rotational axis. The body portionis rotationally disposed within apertures formed in the anvil halfsection and the forward and rearward portions rest against respectiveshoulders of opposed hinge plates extending from the cartridge receivinghalf-section, wherein rotation of the cam about the central rotationalaxis results in the forward and rearward portions of the cam to displacethe cartridge receiving half-section.

According to still another aspect of the present disclosure, a surgicalfastener applying apparatus is disclosed which includes an anvilhalf-section; and a cartridge receiving half-section configured andadapted to releasably mate with the anvil half-section, wherein theproximal end of the cartridge receiving half-section includes a pair ofupstanding juxtaposed pivot plates each including a pin receiving slotformed therein.

It is envisioned that the proximal end of the anvil half-sectionincludes a pin extending laterally from either side thereof, wherein thepin at the proximal end of the anvil half-section is positionable withinthe pin receiving slots formed in the pivot plates of the cartridgereceiving half-section. Preferably, the pin extending laterally from theproximal end of the anvil half-section is non-round, and wherein the pinlimits the angle at which the anvil half-section can be approximated tothe cartridge receiving half-section in order to effectuate properassembly. The angle is preferably less than about 15°. Preferably, thepin has a pear shape cross-section defined by a larger lower portion anda smaller upper portion.

It is envisioned that the surgical fastener applying apparatus includesa firing slide operatively associated with the cartridge receivinghalf-section, the firing slide including a firing lever pivotablycoupled thereto, wherein the firing lever enables the surgical fastenerapplying apparatus to be fired from either side thereof.

It is further envisioned that, the firing slide includes, in oneembodiment, a pair of cam bars configured and adapted to sequentiallyexpel the plurality of fasteners in a direction transverse to thedirection of movement of the pair of cam bars, a knife actuating barpositioned between the pair of cam bars for displacing the knife in thedirection of movement of the cam bars.

It is envisioned that, the firing slide includes, in yet anotherembodiment, a slide block having a hub extending therefrom for receiptin a pivot hole formed in the firing lever; and a pedal having a pinreciprocally received in a hole formed in the slide block, wherein asthe firing slide is displaced in a distal direction the pin from thepedal extends into a recess formed in the firing lever to therebyprevent the firing lever from thereafter pivoting about the hub of theslide block.

In one embodiment, the surgical fastener applying apparatus furtherincludes a replaceable cartridge assembly receivable in the distal endportion of the cartridge receiving half-section, the cartridge assemblyhaving an upper surface and a plurality of surgical staples and surgicalstaple pushers, the surgical staples being ejectable by the pushermembers from the cartridge assembly through openings in the uppersurface, the cartridge assembly defining at least one slot for receivingat least one knife therein, the cartridge assembly including a safetylockout pivotably disposed along the upper surface of cartridge assemblyand movable from an unlocked orientation permitting assembly of theanvil half-section to the cartridge receiving half-section to a lockedorientation preventing assembly of the anvil half-section to thecartridge receiving-half section.

The safety lockout is preferably biased from the unlocked orientation tothe locked orientation. It is envisioned that the safety lockout isbiased by a spring. The safety lockout includes a transverse horizontalsurface formed on the underside thereof which transverse horizontalsurface is configured and adapted to engage a hook formed on an uppersurface of the at least one knife. The transverse horizontal surface andthe hook are configured and dimensioned such that when the at least oneknife is displaced in a distal direction, the hook disengages from thetransverse horizontal surface.

It is envisioned that the cartridge receiving half-section includes aloading and lockout mechanism operatively associated therewith, theloading and lockout mechanism being configured and adapted to facilitateloading of the cartridge assembly to the to the cartridge receivinghalf-section and to prevent firing of the surgical fastener applyingapparatus until the cartridge assembly is properly loaded onto cartridgereceiving half-section. The loading and lockout mechanism includes arocker pivotably mounted to the cartridge receiving half-section, therocker having a locked-out position which prevents firing of thesurgical fastener applying apparatus and a firing position which permitsfiring of the surgical fastener applying apparatus, when in thelocked-out position, the rocker engages a cam bar and preventsdisplacement of the cam bar in a distal direction and when in the firingposition the rocker disengages the cam bar and allows the cam bar to bedisplaced distally.

The rocker defines an upper edge blocking surface, wherein when therocker is in the locked-out position the upper edge blocking surfaceengages a knife actuating bar and prevents displacement of the knifeactuating bar in a distal direction and when the rocker is in the firingposition the upper edge blocking surface disengages the knife actuatingbar and allows the knife actuating bar to be displaced distally. Therocker is preferably biased to the locked-out position. Preferably, therocker is pivoted to the firing position when the anvil half-section iscoupled to the cartridge receiving half-section.

In another embodiment, the surgical fastener applying apparatus includesa gap adjustment mechanism operatively associated between the anvilhalf-section and the cartridge receiving half-section, wherein the gapadjustment mechanism is configured and adapted to vary the size of a gapbetween the distal end portions of the anvil half-section and thecartridge receiving half-section. The gap adjustment mechanism includesa cam positioned between the anvil half-section and the cartridgereceiving half-section when in the mated condition, wherein manipulationof the cam results in the variation of the size of the gap between thedistal ends of the anvil half-section and the cartridge receivinghalf-section.

The cam includes a forward portion, a body portion and a rearwardportion, wherein the body portion of the cam defines a centralrotational axis and wherein the forward and rearward portions share acommon axis which is spaced a distance from the central rotational axis.The body portion is rotationally disposed within apertures formed in theanvil half section and the forward and rearward portions rest againstrespective shoulders of opposed hinge plates extending from thecartridge receiving half-section, wherein rotation of the cam about thecentral rotational axis results in the forward and rearward portions ofthe cam to displace the cartridge receiving half-section. Preferably,the gap adjustment mechanism includes a cam lock configured and adaptedto engage the body portion of the cam and to prevent rotation of the camafter adjustment of the gap.

It is envisioned that the clamping lever includes a body portion havinga pair of juxtaposed hinge plates each defining an access channel formedtherein, wherein each access channel is configured and dimensioned toreceive a respective mounting boss extending laterally from the anvilhalf-section, wherein as the clamping lever is approximated toward thecartridge receiving half-section, the access channels guide the mountingbosses therethrough to properly mate the anvil half-section with thecartridge receiving half-section.

Preferably, when the anvil receiving half-section is oriented in thehorizontal plane and the clamping lever is in the first position, theopening to each access channel can be vertically accessed. It isenvisioned that each access channel is generally orthogonal to thecartridge receiving half-section. It is further envisioned that eachaccess channel faces angularly relative to the cartridge receivinghalf-section.

In yet another aspect of the present disclosure, a surgical fastenerapplying apparatus is provided which includes an anvil half-section, acartridge receiving half-section configured and adapted to releasablymate with the anvil half-section, a replaceable cartridge assemblyreceivable in the distal end portion of the cartridge receivinghalf-section, and a firing slide operatively associated with thecartridge receiving half-section, the firing slide including a firinglever pivotably coupled thereto, wherein the firing lever enables thesurgical fastener applying apparatus to be fired from either sidethereof.

It is envisioned that the firing slide includes a pair of cam barsconfigured and adapted to sequentially expel the plurality of fastenersin a direction transverse to the direction of movement of the pair ofcam bars, a knife actuating bar positioned between the pair of cam barsfor displacing the knife in the direction of movement of the cam bars.

The firing slide includes, in another embodiment, a slide block having ahub extending therefrom for receipt in a pivot hole formed in the firinglever; and a pedal having a pin reciprocally received in a hole formedin the slide block, wherein as the firing slide is displaced in a distaldirection the pin from the pedal extends into a recess formed in thefiring lever to thereby prevent the firing lever from thereafterpivoting about the hub of the slide block.

It is envisioned that the surgical fastener applying apparatus furtherincludes a replaceable cartridge assembly receivable in the distal endportion of the cartridge receiving half-section, the cartridge assemblyhaving an upper surface and a plurality of surgical staples and surgicalstaple pushers, the surgical staples being ejectable by the pushermembers from the cartridge assembly through openings in the uppersurface, the cartridge assembly defining at least one slot for receivingat least one knife therein, the cartridge assembly including a safetylockout pivotably disposed along the upper surface of the cartridgeassembly and movable from an unlocked orientation permitting assembly ofthe anvil half-section, to the cartridge receiving half-section to alocked orientation preventing assembly of the anvil half-section to thecartridge receiving-half section.

Preferably, the safety lockout is biased by a spring. The safety lockoutincludes a transverse horizontal surface formed on the underside thereofwhich transverse horizontal surface is configured and adapted to engagea hook formed on an upper surface of the at least one knife. Thetransverse horizontal surface and the hook are configured anddimensioned such that when the at least one knife is displaced in adistal direction, the hook disengages from the transverse horizontalsurface.

It is envisioned that the cartridge receiving half-section includes aloading and lockout mechanism operatively associated therewith, theloading and lockout mechanism being configured and adapted to facilitateloading of the cartridge assembly to the to the cartridge receivinghalf-section and to prevent firing of the surgical fastener applyingapparatus until the cartridge assembly is properly loaded onto cartridgereceiving half-section.

The loading and lockout mechanism includes a rocker pivotably mounted tothe cartridge receiving half-section, the rocker having a locked-outposition which prevents firing of the surgical fastener applyingapparatus and a firing position which permits firing of the surgicalfastener applying apparatus, when in the locked-out position, the rockerengages a cam bar and prevents displacement of the cam bar in a distaldirection and when in the firing position the rocker disengages the cambar and allows the cam bar to be displaced distally.

The rocker defines an upper edge blocking surface, wherein when therocker is in the locked-out position the upper edge blocking surfaceengages a knife actuating bar and prevents displacement of the knifeactuating bar in a distal direction and when the rocker is in the firingposition the upper edge blocking surface disengages the knife actuatingbar and allows the knife actuating bar to be displaced distally.Preferably, the rocker is biased to the locked-out position. The rockeris pivoted to the firing position when the anvil half-section is coupledto the cartridge receiving half-section.

It is envisioned that the surgical fastener applying apparatus furtherincludes a gap adjustment mechanism operatively associated between theanvil half-section and the cartridge receiving half-section, wherein thegap adjustment mechanism is configured and adapted to vary the size of agap between the distal end portions of the anvil half-section and thecartridge receiving half-section. The gap adjustment mechanism includesa cam positioned between the anvil half-section and the cartridgereceiving half-section when in the mated condition, wherein manipulationof the cam results in the variation of the size of the gap between thedistal ends of the anvil half-section and the cartridge receivinghalf-section.

The earn includes a forward portion, a body portion and a rearwardportion, wherein the body portion of the cam defines a centralrotational axis and wherein the forward and rearward portions share acommon axis which is spaced a distance from the central rotational axis.The body portion is rotationally disposed within apertures formed in theanvil half section and the forward and rearward portions rest againstrespective shoulders of opposed hinge plates extending from thecartridge receiving half-section, wherein rotation of the cam about thecentral rotational axis results in the forward and rearward portions ofthe cam to displace the cartridge receiving half-section. Preferably,the gap adjustment mechanism includes a cam lock configured and adaptedto engage the body portion of the cam and to prevent rotation of the camafter adjustment of the gap.

It is envisioned that the clamping lever includes a body portion havinga pair of juxtaposed hinge plates each defining an access channel formedtherein, wherein each access channel is configured and dimensioned toreceive a respective mounting boss extending laterally from the anvilhalf-section, wherein as the clamping lever is approximated toward thecartridge receiving half-section, the access channels guide the mountingbosses therethrough to properly mate the anvil half-section with thecartridge receiving half-section.

Preferably, when the anvil receiving half-section is oriented in thehorizontal plane and the clamping lever is in the first position, theopening to each access channel can be vertically accessed. It isenvisioned that each access channel is generally orthogonal to thecartridge receiving half-section. It is further envisioned that eachaccess channel faces angularly relative to the cartridge receivinghalf-section.

In one embodiment, the proximal end of the cartridge receivinghalf-section includes a pair of upstanding juxtaposed pivot plates eachincluding a pin receiving slot formed therein. The proximal end of theanvil half-section includes a pin extending laterally from either sidethereof, and wherein the pin at the proximal end of the anvilhalf-section is positionable within the pin receiving slots formed inthe pivot plates of the cartridge receiving half-section. The pinextending laterally from the proximal end of the anvil half-section isnon-round, wherein the pin limits the angle at which the anvilhalf-section can be approximated to the cartridge receiving half-sectionin order to effectuate proper assembly. It is contemplated that theangle is less than about 15°. Preferably, the pin has a pear shapecross-section defined by a larger lower portion and a smaller upperportion.

In yet another aspect of the present disclosure, a staple cartridgeassembly receivable in a distal end portion of cartridge receivinghalf-section of a surgical stapler is disclosed. The staple cartridgeassembly includes a safety lockout pivotably disposed along an uppersurface of the cartridge assembly and movable from an unblockedorientation permitting assembly of an anvil half-section to thecartridge receiving half-section, to a locked orientation preventingassembly of the anvil half-section with the cartridge receivinghalf-section.

The safety lockout is biased from the unlocked orientation to the lockedorientation. The safety lockout is biased by a spring. The safetylockout includes a transverse horizontal surface formed on the undersidethereof and which is configured and adapted to engage a member formed ona surface of the at least one knife. Preferably, the transversehorizontal surface and the member of the at least one knife areconfigured and dimensioned such that when the at least one knife isdisplaced in a distal direction, the member of the at least one knifedisengages from the transverse horizontal surface. It is envisioned thatthe at least one knife is a hook.

It is envisioned that the staple cartridge assembly apparatus furtherincludes a loading and lockout mechanism operatively associatedtherewith, the loading and lockout mechanism being configured andadapted to facilitate loading of the cartridge assembly to the to thecartridge receiving half-section and to prevent firing of the surgicalfastener applying apparatus until the cartridge assembly is properlyassembly with cartridge receiving half-section. The loading and lockoutmechanism includes a rocker pivotably mounted to the cartridge receivinghalf-section, the rocker having a locked-out position which preventsfiring of the surgical fastener applying apparatus and a firing positionwhich permits firing of the surgical fastener applying apparatus, therocker defining a downwardly extending blocking surface which, when inthe locked-out position, the rocker engages a cam bar and preventsdisplacement of the cam bar in a distal direction and when in the firingposition the rocker disengages the cam bar and allows the cam bar to bedisplaced distally.

The rocker defines an upper edge blocking surface, wherein when therocker is in the locked-out position the upper edge blocking surfaceengages a knife actuating bar and prevents displacement of the knifeactuating bar in a distal direction, and when the rocker is in thefiring position the upper edge blocking surface disengages the knifeactuating bar and allows the knife actuating bar to be displaceddistally. Preferably, the rocker is biased to the locked-out position.The rocker is adapted to be pivoted to the firing position when theanvil half-section is coupled to the cartridge receiving half-section.

It is envisioned that the staple cartridge assembly includes a series offinger grips formed along an upper side surface near a proximal endthereof.

In yet another aspect of the present disclosure, a surgical fastenerapplying apparatus is disclosed which includes an anvil half-section;and a cartridge receiving half-section configured and adapted toreleasably mate with the anvil half-section, the cartridge receivinghalf-section including a pivotable clamping lever, wherein the clampinglever includes a body portion having a pair of juxtaposed hinge plateseach defining a reinforced access channel formed therein for receiving arespective mounting boss extending laterally from either side of theanvil half-section. Preferably, the access channels are shaped to guidethe mounting bosses therethrough to properly assemble the anvilhalf-section with the cartridge receiving half-section.

In yet another aspect of the present disclosure, a surgical fastenerapplying apparatus is disclosed including an anvil half-section; and acartridge receiving half-section configured and adapted to releasablymate with the anvil half-section, the cartridge receiving half-sectionincluding a pivotable clamping lever, wherein the clamping leverincludes a body portion having a pair of juxtaposed hinge plates eachdefining an access channel formed therein for receiving a respectivemounting boss extending laterally from either side of the anvilhalf-section, wherein a portion of the respective access channels arecovered by portions of the hinge plate.

These objects together with other objects of the disclosure, along withvarious features of novelty which characterize the disclosure, arepointed out with particularity in the claims annexed hereto and forminga part of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed surgical fastenerapplying apparatus will be described herein with reference to theaccompanying drawing figures wherein;

FIG. 1 is a perspective view of one embodiment of a surgical fastenerapplying apparatus constructed in accordance with the presentdisclosure;

FIG. 2 is a perspective view of a disposable staple cartridge assemblyfor the surgical fastener applying apparatus shown in FIG. 1;

FIG. 3 is a perspective view, with parts separated, of the disposablestaple cartridge assembly of FIG. 2;

FIG. 4 is an enlarged left distal perspective view of an embodiment of astaple cartridge loading and lockout mechanism;

FIG. 5 is an enlarged right side proximal perspective view of theloading and lockout mechanism of FIG. 4;

FIG. 6 is a perspective view, with parts separated, showing coupling ofthe staple cartridge assembly of FIG. 2 on a cartridge receivinghalf-section of the surgical fastener applying apparatus of FIG. 1;

FIG. 7 is an enlarged perspective bottom view of the loading and lockoutmechanism with the staple cartridge assembly of FIG. 2 operativelycoupled thereto;

FIG. 8 is an enlarged perspective view similar to FIG. 5, with thestaple cartridge assembly of FIG. 2 in place;

FIG. 9 is an enlarged side perspective view which shows the relativepositioning of the loading and lockout mechanism with the staplecartridge assembly of FIG. 2 installed and with an anvil half-section inplace in a clamped condition;

FIG. 10 is a perspective view which shows the surgical fastener applyingapparatus of FIG. 1 after partial or complete firing and in an unclampedcondition with a staple cartridge safety lockout in a locked outposition;

FIG. 11 is an enlarged view of the indicated area of detail of FIG. 10;

FIG. 12 is a perspective view with parts separated which shows thestructural relationship of the various components of an embodiment of aclamp lever lockout and safety interlock mechanism of the presentdisclosure;

FIG. 13 is a top plan view of the surgical fastener applying apparatuswith a firing lever in the proximal-most position;

FIG. 14 is a cross-sectional view taken along section line 14-14 of FIG.13;

FIG. 15 is an enlarged view of the indicated area of detail of FIG. 14;

FIG. 16 is an enlarged view of the indicated area of detail of FIG. 14;

FIG. 17 is a plan view similar to FIG. 13, which shows the firing leveradvanced distally a short distance;

FIG. 18 is a cross-sectional view taken along section line 18-18 of FIG.17;

FIG. 19 is an enlarged view of the indicated area of detail of FIG. 18;

FIG. 20 is an enlarged view of the indicated area of detail of FIG. 18;

FIG. 21 is a perspective view of the cartridge receiving half-section ofthe surgical fastener applying apparatus of FIG. 1;

FIG. 22 is a perspective view of a disposable staple cartridge assemblyaccording to an alternative embodiment of the present disclosure;

FIG. 23 is a perspective view, with parts separated, of the disposablestaple cartridge assembly of FIG. 22;

FIG. 24 is a perspective view of the disposable staple cartridgeassembly as shown in FIG. 22 with the shipping wedge removed therefrom;

FIG. 25 is a perspective view of a proximal portion of a cartridgereceiving half-section according to an alternative embodiment of thepresent disclosure;

FIG. 26 is an enlarged left distal perspective view of a staplecartridge loading and lockout mechanism according to the alternativeembodiment of FIG. 25;

FIG. 27 is an enlarged right side proximal perspective view of theloading and lockout mechanism of FIG. 26;

FIG. 28 is an enlarged bottom side perspective view of the loading andlock out mechanism of FIG. 26 with a staple cartridge assembly in placethereon;

FIG. 29 is a partially exploded enlarged bottom side perspective viewsimilar to that of the loading and lock out mechanism shown in FIG. 28;

FIG. 30 is an enlarged top side perspective view similar to the loadingand lock out mechanism of FIG. 27;

FIG. 31 is an enlarged side perspective view which shows the relativepositioning of the loading and lockout mechanism with an anvilhalf-section in place thereon;

FIG. 32 is a perspective view of the surgical fastener applyingapparatus of FIGS. 21-40, in an unclamped condition, with a cartridgereceiving half-section clamp lever in an open position;

FIG. 33 is a perspective view, with parts separated, which shows thestructural relationship of the various components of a clamp leverlockout and safety interlock mechanism;

FIG. 34 is a cross-sectional view of the surgical fastener applyingapparatus of FIGS. 21-40, in a pre-fired condition, taken along thelongitudinal center line thereof;

FIG. 35 is an enlarged view of the indicated area of detail of FIG. 34;

FIG. 36 is an enlarged view of the indicated area of detail of FIG. 34;

FIG. 37 is a cross-sectional view of the surgical fastener applyingapparatus of FIGS. 21-40, in a post-fired condition, taken along thelongitudinal center line thereof;

FIG. 38 is an enlarged view of the indicated area of detail of FIG. 37;

FIG. 39 is an enlarged view of the indicated area of detail of FIG. 37;

FIG. 40 is a perspective view of the cartridge receiving half-section ofthe surgical fastener applying apparatus of FIGS. 21-40 after partial orcomplete firing with a staple cartridge safety lockout in a locked outposition;

FIG. 41 is a schematic perspective view of a surgical fastener applyingapparatus according to another alternative embodiment of the presentdisclosure, with a cartridge receiving half-section clamp lever shown inan open position;

FIG. 42 is an enlarged schematic perspective view of the mountingbracket of the cartridge receiving half-section clamp lever shown inFIG. 41;

FIG. 43 is an enlarged schematic perspective view of an alternateembodiment of a mounting bracket for the cartridge receivinghalf-section clamp lever shown in FIG. 41 with the cartridge receivinghalf-section clamp lever shown in an open condition;

FIG. 44 is an enlarged perspective view of the mounting bracket of FIG.43 with the cartridge receiving half-section clamp lever shown in aclosed condition;

FIG. 45 is a cross-sectional view of the mounting bracket of FIG. 43taken along section line 45-45;

FIG. 46 is a cross-sectional view of the mounting bracket of FIG. 43taken along section line 46-46;

FIG. 47 is an enlarged schematic perspective view of the mountingbracket of FIG. 43 with a handle cover covering each of the cartridgeand the anvil half-section clamp levers;

FIG. 48 is an enlarged perspective view of the underneath of a proximalend of an anvil frame side with the anvil half-section clamp lever inthe closed position;

FIG. 49 is a perspective view of the proximal end of the surgicalfastener applying apparatus depicting the engagement of the proximalends of the cartridge and anvil half-section clamp levers;

FIG. 50 is a perspective view of still another embodiment of a surgicalfastener applying apparatus constructed in accordance with the presentdisclosure;

FIG. 51 is a perspective view of the surgical fastener applyingapparatus of FIG. 50 opened from a cartridge receiving half-section sidewith a cartridge receiving half-section clamp lever opened;

FIG. 52 is an enlarged perspective view of the indicated area of FIG.51;

FIG. 53 is an enlarged perspective view of a distal end of the surgicalfastener applying apparatus of FIG. 50;

FIG. 54 is a distal side perspective view of the surgical fastenerapplying apparatus of FIG. 50 with the contoured handles removedtherefrom;

FIG. 55 is a rear perspective view of the surgical fastener applyingapparatus of FIG. 54;

FIG. 56 is a perspective view, with parts separated, of the surgicalfastener applying apparatus of FIG. 50;

FIG. 57 is a perspective view, with parts separated, of the anvilhalf-section side of the surgical fastener applying apparatus of FIG.50;

FIG. 58 is an enlarged perspective view of an eccentric cam inaccordance with the present disclosure;

FIG. 58A is a side elevational view of the eccentric cam as shown inFIG. 58;

FIG. 58B is a rear elevational view of the eccentric cam as shown inFIG. 58;

FIG. 59 is a perspective view of the anvil half-section side of thesurgical fastener applying apparatus of FIG. 50, as seen from thebottom;

FIG. 60 is an enlarged view of the indicated area of FIG. 59;

FIG. 61 is an enlarged view of the indicated area of FIG. 59;

FIG. 62 is a side elevational view of the anvil half-section detailingthe eccentric cam of FIG. 58;

FIG. 63 is a cross-sectional view, taken along the longitudinal axis, ofthe anvil half-section as seen in FIG. 62;

FIG. 64 is a side elevational view of the anvil and cartridge receivinghalf-sections coupled to one another detailing the operation of theeccentric cam of FIG. 58;

FIG. 65 is a side-elevational view of the anvil and cartridge receivinghalf-sections coupled to one another further detailing the operation ofthe eccentric cam of FIG. 58;

FIG. 66 is a top perspective view of the cartridge receivinghalf-section shown with the clamp lever in the open position;

FIG. 67 is a perspective view, with parts separated, of the disposablestaple cartridge assembly of the surgical stapler applying apparatus ofFIG. 50;

FIG. 68 is a perspective view, as seen from the bottom, of a safety lockout of an embodiment of the present disclosure;

FIG. 69 is a perspective view of a firing slide, as seen from thebottom, of the surgical fastener applying apparatus of FIG. 50;

FIG. 70 is a perspective view, with parts separated, of the firing slideof FIG. 69;

FIG. 71 is a perspective view of a proximal end of the center bar of thefiring slide of FIG. 69;

FIG. 72 is a top perspective view of a proximal end of the firing slideof FIG. 69;

FIG. 73 is a perspective view of a slide block of the firing slide ofFIG. 69;

FIG. 74 is a bottom perspective view of a firing lever of the firingslide of FIG. 69;

FIG. 75 is a cross-sectional view of the proximal end of the firingslide of FIG. 69;

FIG. 76 is a perspective view of the lock out mechanism of the surgicalfastener applying apparatus of FIG. 50;

FIG. 77 is a perspective view, with parts separated, of the cartridgereceiving half-section frame of the surgical fastener applying apparatusof FIG. 50;

FIG. 78 is a bottom perspective view of the cartridge receivinghalf-section frame of FIG. 77;

FIG. 79 is a perspective view of a cartridge receiving half-section sideof the surgical fastener applying apparatus of FIG. 50;

FIG. 80 is an enlarged view of the indicated area of detail of FIG. 79;

FIG. 81 is an enlarged view of the indicated area of detail of FIG. 79;

FIG. 82 is a perspective view of a handle cover for the cartridge leverof the surgical fastener applying apparatus of FIG. 50;

FIG. 83 is a perspective view of a cartridge receiving half-sectionclamp lever of the surgical fastener applying apparatus of FIG. 50;

FIG. 84 is another perspective view of the cartridge receivinghalf-section clamp lever of FIG. 50;

FIG. 85 is a perspective view of a cartridge lever release member;

FIG. 86 is a perspective view of a leaf spring mounting plug of thesurgical fastener applying apparatus of FIG. 50;

FIG. 87 is a cross-sectional view of the surgical fastener applyingapparatus, taken along the longitudinal axis, depicting the coupling ofthe cartridge receiving half-section to the anvil half-section;

FIG. 88 is an enlarged view of the indicated area of detail of FIG. 87;

FIG. 89 is an enlarged view of the indicated area of detail of FIG. 87;

FIG. 90 is an enlarged view of the indicated area of detail of FIG. 87;

FIG. 91 is an enlarged side elevational view of the proximal end ofanvil half-section being coupled to the cartridge receivinghalf-section;

FIG. 92 is a cross-sectional view, taken along the longitudinal axis, ofthe surgical fastener applying apparatus of FIG. 50, in a closedpre-firing condition;

FIG. 93 is an enlarged view of the indicated area of detail of FIG. 92;

FIG. 94 is an enlarged view of the indicated area of detail of FIG. 92;

FIG. 95 is a top plan view of the surgical fastener applying apparatusof FIG. 50, in a post-firing condition;

FIG. 96 is a cross-sectional view, taken along the longitudinal axis, ofthe surgical fastening applying apparatus of FIG. 50, in the post-firingcondition;

FIG. 97 is an enlarged view of the indicated area of detail of FIG. 96;

FIG. 98 is an enlarged view of the indicated area of detail of FIG. 96;

FIG. 99 is a perspective view of the surgical fastener applyingapparatus of FIG. 50, in an open post-firing condition;

FIG. 100 is an enlarged view of the indicated area of detail of FIG. 99;

FIG. 101 is a cross-sectional view of the surgical fastener applyingapparatus of FIG. 50, in an open post-firing condition, taken along thelongitudinal axis; and

FIG. 102 is an enlarged view of the individual area of detail of FIG.101.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of surgical fastener applying apparatus inaccordance with the present disclosure will now be described in detailwith reference to the drawing figures wherein like reference numeralsidentify similar or identical structural elements. As shown in thedrawings and described throughout the following description, as istraditional when referring to relative positioning on a surgicalinstrument, the term “proximal” refers to the end of the apparatus whichis closer to the user and the term “distal” refers to the end of theapparatus which is further away from the user.

Referring initially to FIGS. 1-22, an illustrative embodiment of thepresently disclosed surgical fastener applying apparatus is illustratedtherein and designated generally as surgical stapler 10. Surgicalstapler 10 is particularly adapted to apply a plurality of adjacent rowsof staples to body tissue clamped in between the instrument's twoprinciple sections, a cartridge receiving half-section 12 and an anvilhalf-section 14. Typical applications of the presently disclosedsurgical fastener apparatus are, for example, creating a hemostatic sealin general, thoracic, and urologic surgery for resection, transectionand creation of anastomoses. Specific tissue structures in which theinstrument may be used are, for example, the stomach, the large andsmall bowels, lungs and the esophagus.

Turning now to FIGS. 2 and 3, surgical stapler 10 is designed for usewith a disposable staple cartridge assembly 16, such as, for example, asingle use disposable loading unit (“SULU”). Cartridge assembly 16includes a cartridge body 18, a plurality of staple pushers 20, a bottomcover 22, a knife 24 having an angled sharpened leading edge 24 a, aplurality of staples 26, a pivotably mounted safety lockout 28 and aremovable shipping wedge 30. As with known staple cartridge designs,cartridge body 18 has a plurality of rows of staple retaining slots 32formed therein. Surgical stapler 10 may be manufactured and assembled indifferent sizes to receive different size cartridge assemblies 16. Forexample, surgical stapler 10 can be made in different sizes to acceptcartridge assemblies 16 having staple line lengths of approximately 60mm, 80 mm, and 100 mm.

Alternatively, cartridge assemblies 16 may be adapted such that onecommon surgical stapler 10 will accept multiple different staple countcartridge assemblies. For example, cartridge assemblies 16 may beconfigured such that each different staple count cartridge assemblyshares a common size cartridge body 18 to facilitate mounting onsurgical stapler 10.

In the illustrated embodiment, there are two staggered rows of slots 32formed on either side of a linear slotted track 34 which guides knife 24during its longitudinal movement. A single staple 26 is positioned ineach of slots 32. The staple rows preferably extend a distance distallybeyond the distal end of knife track 34 to facilitate staple formationbeyond the stroke length of knife 24.

Staple pushers 20 are aligned one each with slots 32 such that a singlestaple pusher member 20 is positioned under a respective staple 26 whichis retained within slot 32. Staple pushers 20 are formed such that theyare attached to each other in groups of two offset oriented pusher pairsand have an actuating surface (not shown) connecting each pair of pushermembers 20.

Staple pushers 20 are arranged in two series, one on each side ofslotted track 34, such that the actuating surfaces of each series ofstaple pushers 20 forms a line centered between the staggered rows ofstaples 26. The actuating surfaces act as cam followers and interactwith a pair of staggered camming surfaces 36, 38 extending from agenerally U-shaped cam bar 40 (see FIGS. 4 and 5) to expel the pairs ofstaples 26 on each side of knife track 34. As illustrated, cammingsurfaces 36, 38 form a single angle relative to horizontal. In certainapplications, for example, with staples having an unformed leg height ofabout 4.5 mm, camming surfaces 36, 38 may be formed of a plurality ofangles to facilitate optimal staple deformation with a given firingforce, as cam bar 40 is moved distally. This sequence is repeated untilthe distal movement of cam bar 40 is either stopped intentionally by theuser to form less than all of staples 26 or until all of staples 26 areexpelled from cartridge assembly 16.

Bottom cover 22 partially encloses the bottom of a channel formed by theupper surface of the channel bottom wall and the side walls of cartridgebody 18. A longitudinal ridge 22 a is formed on an upper surface ofbottom cover 22 and serves as a bearing surface for knife bearingchannel 42, which is secured to the bottom edge of knife 24, as ittravels in knife track 34. A pair of slots are formed, one on eitherside of longitudinal ridge 22 a, the outer limit of each slot beingdefined by the outer side wall of cartridge body 18 on a respective sideof ridge 22 a. These slots facilitate reciprocating longitudinalmovement of the extensions of camming surfaces 36, 38 of generallyU-shaped cam bar 40. Knife bearing channel member 42 which is preferablywider than knife track 34, is secured to the bottom surface of the knife24 such that knife bearing channel member 42 rides between knife track34 and longitudinal ridge 22 a of bottom cover 22. In this manner, knife24 is prevented from undergoing substantial vertical movement duringlongitudinal translation in knife track 34.

Safety lockout 28 is pivotably disposed on the upper proximal end ofcartridge body 18 and is movable from a locked orientation to anunlocked orientation. Preferably, safety lockout 28 is biased away fromthe unlocked orientation towards an orientation substantiallyperpendicular to the longitudinal axis of cartridge body 18. Anysuitable bias member may be utilized such as, for example, springs 44,46. To overcome the bias towards the perpendicular orientation, safetylockout 28 includes a transverse horizontal surface 28 a, preferably aprojection (see FIG. 15) formed on the underside thereof which engages amember, preferably a projection or a hook 24 b formed on the upper edgesurface of knife 24. This cooperative engagement serves to retain safetylockout 28 in the locked orientation wherein safety lockout 28 coversknife 24.

When surgical stapler 10 has been unclamped, as will be described ingreater detail further herein, after either partial or complete firingof surgical stapler 10, safety lockout 28 is biased to the perpendicularorientation (see FIGS. 10 and 11), extending upwardly away fromcartridge receiving half-section 12. In this manner, safety lockout 28prevents surgical stapler 10 from being re-clamped until the partial orcompletely fired cartridge assembly 16 is removed and replaced with anew cartridge assembly 16. Safety lockout 28 also provides a cut-outgrasping surface 28 b with which cartridge assembly 16 may readily beremoved from surgical stapler 10.

As previously noted, shipping wedge 30 is removably attachable tocartridge body 18. When installed on cartridge assembly 16, shippingwedge 30 covers the entire surface area of staple rows 26 and knifetrack 34. Additionally, shipping wedge 30 includes an abutment 30 aextending upwardly and proximally from an upper proximal surfacethereof. Abutment 30 a in cooperation with safety lockout 28 coverssharpened distal edge 24 a of knife 24. This feature prevents knife 24from being exposed to the user during handling of cartridge assembly 16.Additionally, abutment 30 a prevents premature pivotal movement ofsafety lockout 28 from the locked orientation. Thus, even if cartridgeassembly 16 is properly loaded on surgical stapler 10, staples 26 cannotbe fired until shipping wedge 30 is first removed.

Shipping wedge 30 also includes a post 30 b extending downwardly fromthe underside thereof near the proximal end. Post 30 b fits into acomplementary shaped opening 18 c formed in cartridge body 18 at theproximal end of knife track 34. With shipping wedge 30 in place, post 30b blocks potential distal movement of knife 26. In an alternativeembodiment, cartridge assemblies 16 may also be provided without a knifein applications where it is desirable to perform stapling withouttransection. In such an embodiment, knife 26 is replaced with a blankelement to substitute for the knife to interact with safety lockout 28.

Cartridge body 18 is provided with several shaped surfaces to facilitatemounting and alignment of cartridge assembly 16 with respect tocartridge receiving half-section 12 of surgical stapler 10. Suchalignment facilitating surfaces may be formed at any suitable locationon the various components of cartridge body 18 to correspond withcomplementary surfaces on cartridge receiving half-section 12. In theillustrated embodiment, locating/alignment feature surfaces 18 a areformed extending downwardly on either side of cartridge assembly 16 nearthe proximal end thereof and molded surfaces 18 b are formed on eitherside of cartridge body 18 near the distal end thereof. When cartridgeassembly 16 is properly installed on surgical stapler 10, surfaces 18 aseat in a pair of notches 48, 50 (see FIGS. 4, 5, 6 and 8) formed incartridge receiving half-section 12.

Referring to FIGS. 4-9, a loading and lockout mechanism 50 for cartridgeassembly 16 will now be described in detail. In these figures, a channelframe 12 a (see FIG. 12) of cartridge receiving half-section 12 is notshown so that loading and lockout mechanism 50 can be illustrated moreclearly. Loading and lockout mechanism 50 facilitates loading ofcartridge assembly 16 and prevents firing of surgical stapler 10 untilcartridge assembly 16 is properly loaded or assembled on cartridgereceiving half-section 12 and surgical stapler 10 is properly clampedshut. Loading and lockout mechanism 50 includes a rocker 52 which ispivotably mounted to channel frame 12 a (see FIG. 12) of cartridgereceiving half-section 12 by way of transversely extending post portions52 a seating in openings formed through the sidewalls of channel frame12 a. Post portions 52 a are provided with angled downwardly orientedsurfaces to facilitate assembly of rocker 52 with channel frame 12 a.Rocker 52 is preferably a molded plastic component and is provided withthree slots, namely open bottomed slots 52 b, 52 c to permitlongitudinal movement of cam bar 40 and a closed slot 52 d to permitpassage of a center bar 54 (see FIG. 4) therethrough.

As best shown in FIGS. 5 and 7, rocker 52 is further provided with adownwardly extending blocking surface 52 e which is in verticalalignment with an opening 40 a formed through the bottom surface of cambar channel 40 when cam bar channel 40 is in its proximal-most position.Rocker 52 is biased, by way of a spring 56 which is disposed betweendownwardly extending leg 52 f and an end wall 58 a of a beam member 58,toward a locked-out vertical or upstanding position wherein blockingsurface 52 e extends through opening 40 a. In this manner, cam bar 40 isprevented from distal longitudinal movement. In versions of surgicalstapler 10 using shorter cartridge assemblies 16, beam member 58 may beeliminated.

Upon loading of cartridge assembly 16 on cartridge receivinghalf-section 12, as shown in FIG. 8, the spring bias of spring 56maintains rocker 52 in the locked-out position. It is only when anvilhalf-section 14 is joined with cartridge receiving half-section 12 andthe half-sections clamped together, as seen in FIG. 9, thereby causingdownwardly extending leg portions 60 a formed on either side of anvilhalf-section channel member 60 to bias against cartridge assembly 16,that rocker 52 is urged to rotate by the camming action of proximal endsurface of cartridge assembly 16 against the distal end surface 51 ofrocker 52. In this manner, blocking surface 52 e is moved out of (i.e.,pivoted out of) longitudinal alignment with opening 40 a of cam barchannel 40 thereby permitting a distal longitudinal movement of cam barchannel 40.

Referring to FIGS. 10 and 11, once surgical stapler 10 has been at leastpartially fired, if the instrument is opened, safety lockout 28 ofcartridge assembly 16 automatically moves to the perpendicularorientation due to the spring bias mounting thereof. With safety lockout28 in this orientation, surgical stapler 10 cannot be re-clamped. Thus,if the user desires to apply further staples, partially or completelyfired cartridge assembly 16 must first be removed and replaced with anon-fired cartridge assembly 16.

As will be described in greater detail below and as seen in FIGS. 12 and21, surgical stapler 10 is provided with a pivotably mounted firinglever 65. Pivotally mounted firing lever 65 provides the user with theability to fire surgical stapler 10 from either the left or right side.

Referring to FIG. 12, surgical stapler 10 is provided with a clampinglever 62 pivotably mounted to cartridge receiving half-section 12. Anergonomic contoured handle 66 (sec FIG. 10) is secured to clamping lever62 to provide the user with a convenient gripping handle. To furtherenhance the gripping of surgical stapler 10 by the user, a frictionenhancing insert 70 (see FIG. 10) is secured to handles 66 and 68.Insert 70 may be formed of any suitable friction enhancing material, forexample, rubber. As seen in FIG. 10, anvil half-section 14 is providedwith an ergonomic contoured handle 68 secured to anvil half-sectionchannel member 60 to provide the user with a convenient gripping handle.Half-sections 12 and 14 are preferably configured and dimensioned toprovide the user with the ability to reach around both halves andcomfortably close surgical stapler 10 with a one-handed operation inorder to approximate the half-sections and clamp the captured tissue.

Referring also to FIGS. 14-16 and 18-20, a clamp latch and safetyinterlock mechanism 70 is provided at the proximal end of surgicalstapler 10. Clamp latch and safety interlock mechanism 70 serves toretain clamp lever 62 in a clamped orientation as well as to provide asafety interlock which prevents opening of clamp lever 62 once firinglever 65 is moved distally. Cartridge receiving half-section 12 isprovided with a clamp latch and safety interlock mechanism 70 whichworks to latch clamp lever 62 in a clamped configuration upon squeezingclamp lever 62 to the closed position. While a clamp lever 62 is shownand described as being pivotably mounted to cartridge receivinghalf-section 12, it is envisioned that a clamp lever can be pivotablymounted to anvil half-section 14 or a clamp lever can be pivotablymounted to each of cartridge receiving half-section 12 and anvilhalf-section 14. Accordingly, the following description of the variouscomponents which make up the assembly will be directed to that for thecartridge receiving half-section 12 as shown in FIG. 12.

Clamp latch and safety interlock mechanism 70 includes a distal clamplever latch 74 and a proximal interlock latch 76 which is spring biaseddistally toward a latched position. As seen in FIG. 16, when surgicalstapler 10 is in the clamped configuration with firing lever 65 in theproximal-most position, a firing slide block 78 biases latch 76proximally to overcome the distal spring bias to position ledge 76 a oflatch 76 out of lateral alignment with proximal ledge 74 a formed onlatch 74 thereby positioning and maintaining latch 76 in an unlatchedposition. In this position, the user may unclamp clamp lever 62 bysqueezing spring biased finger pad portions 80 a, 80 b of latch handlerelease member 80 (see FIG. 12) which urges latch 74 proximally suchthat distal ledge 74 b is moved out of lateral alignment with theblocking structure formed on cartridge receiving half-section 12 a (notshown).

Once firing lever 65 is moved distally to begin the firing sequence ofsurgical stapler 10, as shown in FIGS. 17, 18 and 20, slide block 78 isalso moved distally thereby removing the biasing force which overcamethe distal spring bias of latch 76. Thus, ledge 76 a moves into lateralalignment with ledge 74 a of latch 74 thereby preventing clamp lever 62from being opened until firing lever 65 is once again moved to theproximal-most position. The instrument is thereby prevented from openingduring the firing stroke.

Upon initial distal movement, firing lever 65 becomes locked-out frompivotal movement by way of firing lever 65 being cammed upwardly toovercome an upward spring bias, as shown in the operationallyprogressive views of FIGS. 16 and 20. In particular, as best shown inFIG. 21, recessed notches 65 a, 65 b are formed as keyways which engagea key 78 a formed on slide block 78, respectively, depending upon whichside of firing lever 65 is employed to actuate firing. Firing lever 65can be returned to the proximal-most position at any time during thefiring stroke. Firing lever 65 must be returned to the proximal-mostposition before the lever can be released and the instrument unclamped.As described previously, if the instrument is opened after firing,either partially or completely, safety lockout 28 on cartridge assembly16 is configured to prevent the user from re-clamping the instrument.

Turning now to FIGS. 22-41, an alternative embodiment of a disposablestaple cartridge assembly is generally shown as 116. As seen in FIGS.22-24, staple cartridge assembly 116 includes a cartridge body 118, aplurality of staple pushers 120, a bottom cover 122, a knife 124 havingan angled sharpened leading edge 124 a and an atraumatic forward tip 124c, a plurality of staples 126, a pivotably mounted safety lockout 128and a removable shipping wedge 130. As with known staple cartridgedesigns, cartridge body 118 has a plurality of rows of staple retainingslots 132 formed therein.

Alternatively, cartridge assembly 116 may be adapted such that onecommon surgical stapler 100 (see FIG. 33) will accept multiple differentstaple count cartridge assemblies 116. For example, cartridge assembly116 may be configured such that each different staple count cartridgeassembly 116 shares a common size cartridge body 118 to facilitatemounting on surgical stapler 100.

In the present illustrated embodiment, there are two staggered rows ofslots 132 formed on either side of a linear slotted track 134 whichguides knife 124 during its longitudinal movement. A single staple 126is positioned in each of slots 132. The staple rows preferably extend adistance distally beyond the distal end of knife track 134 to facilitatestaple formation beyond the stroke length of knife 124. Staple pushers120 are formed such that they are attached to each other in groups oftwo offset oriented pusher pairs.

Staple pushers 120 are arranged in two series, one on each side ofslotted track 134, such that the actuating surfaces of each series ofstaple pushers 120 forms a line centered between the staggered rows ofstaples 126. The actuating surfaces act as cam followers and interactwith a pair of staggered camming surfaces 136 and 138 extending from apair of cam bars 140 (see FIGS. 25-27) to expel the pairs of staples 126on each side of knife track 134. As illustrated, camming surfaces 136and 138 form a single angle relative to horizontal as each cam bar 140is moved distally. This sequence is repeated until the distal movementof each cam bar 140 is either stopped intentionally by the user to formless than all of staples 126 or until all of staples 126 are expelledfrom cartridge assembly 116.

Bottom cover 122 partially encloses the bottom of a channel formed bythe upper surface of the channel bottom wall and the side walls ofcartridge body 118. A longitudinal ridge 122 a is formed on an uppersurface of bottom cover 122 and serves as a bearing surface for knifebearing channel 142, which is secured to the bottom edge of knife 124,as knife 124 travels in knife track 134. A pair of slots is formed oneon either side of longitudinal ridge 122 a, the outer limit of each slotbeing defined by the outer side wall of cartridge body 118 on arespective side of ridge 122 a. These slots facilitate reciprocatinglongitudinal movement of the extensions of camming surfaces 136, 138 ofgenerally U-shaped cam bar 140. Knife bearing channel member 142 whichis preferably wider than knife track 134, is secured to the bottomsurface of knife 124 such that knife bearing channel member 142 ridesbetween knife track 134 and longitudinal ridge 122 a of bottom cover122. In this manner, knife 124 is prevented from undergoing substantialvertical movement during longitudinal translation in knife track 134.

Safety lockout 128 is pivotably disposed on the upper proximal end ofcartridge body 118 and is movable from a locked orientation to anunlocked orientation. Preferably, safety lockout 128 is biased away fromthe locked orientation towards an orientation substantiallyperpendicular to the longitudinal axis of cartridge body 118. Anysuitable bias member may be utilized such as, for example, spring 144.To overcome the bias towards the perpendicular orientation, safetylockout 128 includes a transverse horizontal surface 128 a (see FIG. 35)formed on the underside thereof which engages a hook 124 b formed on theupper edge surface of knife 124. This cooperative engagement serves toretain safety lockout 128 in the locked orientation when safety lockout128 covers knife 124.

When surgical stapler 100 has been unclamped, as will be described ingreater detail further herein, after either partial or complete firing,safety lockout 128 is biased to the perpendicular orientation (see FIG.40), extending upwardly away from cartridge receiving half-section 112.In this manner, safety lockout 128 prevents surgical stapler 100 frombeing re-clamped until the partial or completely fired cartridgeassembly 116 is removed and replaced with a new cartridge assembly 116.Safety lockout 128 also provides a cut-out grasping surface 128 b withwhich cartridge assembly 116 may readily be removed from surgicalstapler 100.

As previously noted, shipping wedge 130 is removably attachable tocartridge body 118. When installed on cartridge assembly 116, shippingwedge 130 covers the entire surface area of staple rows 126 and knifetrack 134. Shipping wedge 130 includes a post 1306 extending downwardlyfrom the underside thereof near the proximal end thereof. Post 130 bfits into a complementary shaped opening 118 c formed in cartridge body118 at the proximal end of knife track 134. With shipping wedge 130 inplace, post 130 b blocks potential distal movement of knife 126. Post130 b maintains knife 134 retained within safety lockout 128 therebyensuring that the sharpened distal edge 124 a of knife 124 is covered.Once again, cartridge assembly 116 may be provided without a knife inapplications where it is desirable to perform stapling withouttransection. In such an embodiment, knife 126 is replaced with a blankelement to substitute for the knife to interact with safety lockout 128.

Cartridge body 118 includes a series of finger grips 127 formed alongthe upper sides near a proximal end thereof. Finger grips 127 assist theuser in gripping cartridge assembly 116 for both installation andremoval of cartridge assembly 116 from cartridge receiving half-section112. Cartridge body 118 also includes a pair of resilient frictionfingers 129 disposed on either side near a proximal end thereof.Friction fingers 129 are configured and adapted to project outwardlyfrom cartridge body 118 and to frictionally engage the inner surface ofcartridge receiving half-section 112. In this manner, the frictionfingers 129 prevent cartridge assembly 116 from falling out of thecartridge receiving half-section 112.

Referring to FIGS. 25-31, a loading and lockout mechanism 150 forcartridge assembly 116 will now be described in detail. Loading andlockout mechanism 150 facilitates loading of cartridge assembly 116 andprevents firing of surgical stapler 100 until cartridge assembly 116 isproperly loaded on cartridge receiving half-section 112 and surgicalstapler 100 is properly clamped shut. Loading and lockout mechanism 150includes a rocker 152 which is pivotably mounted to a channel frame 112a (see FIG. 31) of cartridge receiving half-section 112 by way oftransversely extending post portions 152 a seating in openings formedthrough the sidewalls of channel frame 112 a. Post portions 152 a areprovided with angled downwardly oriented surfaces to facilitate assemblyof rocker 152 with channel frame 112 a. Rocker 152 is preferably amolded plastic component and is provided with three slots, namely openbottomed slots 152 b, 152 c to permit longitudinal movement of cam bar140 and a closed slot 152 d to permit passage of a center bar 154 (seeFIG. 27) therethrough.

As best shown in FIG. 28, rocker 152 is further provided with adownwardly extending blocking surface 152 e which is in verticalalignment with an opening 140 a formed through the bottom surface ofeach cam bar 140 when each cam bar 140 is in its proximal-most position.Rocker 152 is biased, by way of a spring 156 which is disposed ontransversely extending post portion 152 a and between a ridge 152 fformed on a side of the rocker 152 and upper surface of the cartridgehalf section 112 (see FIG. 26), toward a locked-out position whereinblocking surface 152 e extends through opening 140 a. In this manner,each cam bar 140 is prevented from distal longitudinal movement.

Upon loading cartridge assembly 116 on cartridge receiving half-section112 as shown in FIGS. 26-31, the spring bias maintains rocker 152 in thelocked-out position. It is only when anvil half-section 114 is joinedwith cartridge receiving half-section 112 and the half-sections clampedtogether, thereby causing downwardly extending leg portions 160 a formedon either side of anvil half-section channel member 160 to bias againstcartridge assembly 116, that rocker 152 is urged to rotate by thecamming action of proximal end surface of cartridge assembly 116 againstthe distal end surface of rocker 152. In this manner, blocking surface152 e is moved out of (i.e., pivoted out of) longitudinal alignment withopening 140 a of each cam bar 140 thereby permitting a distallongitudinal movement of cam bar 140.

Similar to the embodiment shown in FIGS. 2-21, once surgical stapler 100has been at least partially fired, if the instrument is opened, safetylockout 128 of cartridge assembly 116 automatically moves to theperpendicular orientation due to the spring bias mounting thereof. Withsafety lockout 28 in this orientation, surgical stapler 100 cannot bere-clamped. Thus, if the user desires to apply further staples, fired orpartially fired cartridge assembly 116 must first be removed andreplaced with a non-fired cartridge assembly 116.

Referring to FIG. 32, surgical stapler 100 is provided with clampinglever 162 and a pivotably mounted firing lever 165. Like firing lever 65of the first embodiment, firing lever 165 of the present embodimentprovides the user with the ability to fire surgical stapler 100 fromeither the left or right side.

Clamping lever 162 is pivotably mounted to cartridge receivinghalf-section 112. An ergonomic contoured handle 166 is secured toclamping lever 162 to provide the user with a convenient grippinghandle. To further enhance the gripping of surgical stapler 100 by theuser, a friction enhancing insert 170 is secured to handle 166.

Unlike the embodiment of FIGS. 2-21, the surgical stapler 100 of FIGS.22-41 does not include a clamp latch safety interlock mechanism. In thismanner, the user can open the surgical stapler 100 after a complete orpartial firing of the cartridge assembly 116. Referring now to FIGS.33-39, a clamp latch mechanism, according to the alternative embodiment,is provided at the proximal end of surgical stapler 100 which serves toretain clamp lever 162 in a clamped orientation. Cartridge receivinghalf-section 112 is provided with a clamp latch mechanism which works tolatch clamp lever 162 in a clamped configuration upon squeezing clamplever 162 to the closed position. Once again, while a single clamp lever162 is shown and described as being pivotably mounted to cartridgereceiving half-section 112, it is envisioned that a clamp lever can bepivotably mounted to anvil half-section 114 or a clamp lever can bepivotably mounted to each of cartridge receiving half-section 112 andanvil half-section 114. Accordingly, the following description of thevarious components which make up the clamp latch mechanism will bedirected to that for the cartridge receiving half-section 112.

As shown in FIG. 33, the clamp latch mechanism includes a distal clamplever latch 174 formed at a proximal end of the cartridge receivinghalf-section 112 and latch handle release member 180 operatively coupledto a proximal end of clamp lever 162. Latch handle release member 180 isspring biased proximally toward a latched position and is provided witha catch 182 (see FIG. 36) for engaging clamp lever latch 174. In orderto release clamp lever 162, the user presses release member 180 in thedistal direction, thereby disengaging catch 182 from latch 174.

In order to prevent inadvertent opening of the clamp lever 162, releasemember 180 is provided with a projection 184 extending downwardly from aproximal end thereof, which projection 184 is seated within a guard 186formed at the proximal end of the lever 162. It is envisioned that theguard 186 can be integral with the handles 166 and 168 and made of aresilient material to enable the user to more easily move the guard 186and thereby depress the release member 180.

Further, as seen in FIG. 33, surgical stapler 100 is provided with afiring lever slide block 188. Slide block 188 includes a hub 190projecting therefrom and configured and adapted to be received in apivot hole 192 formed in firing lever 165. Slide block 188 is configuredand adapted to be slidably received in the cartridge receivinghalf-section 112. In use, firing lever 165 is pivotable about hub 190thereby providing the user with the ability to manipulate firing lever165 from either side of the surgical stapler 100.

As seen in FIGS. 32-35, 37, 38 and 40, surgical stapler 100 is providedwith a staple gap adjustment mechanism 200 which enables each stapler100 to be manufactured and assembled with a very precise staple gapbetween the cartridge assembly and the anvil structure of the surgicalstapler. The staple gap adjustment mechanism 200 shown in FIGS. 32-35,37, 38 and 40 is the subject of commonly owned and co-pendingInternational Application PCT/US02/31963 filed on Oct. 4, 2002 whichclaims the benefit of and priority to U.S. Provisional Application Ser.No. 60/327,369, filed on Oct. 5, 2001, entitled “Surgical StaplingApparatus”, the entire contents of which are incorporated herein byreference. According to the present embodiment, gap adjustment mechanism200 includes a pair of upstanding hinge plates 202 formed along thesides of the cartridge receiving half-section 112, and an eccentric cam206. Each hinge plate 202 is provided with a coaxial through hole 204which is configured and adapted to receive the eccentric cam 206therein. In use, as eccentric cam 206 is rotated, a central portion, forexample, 474 in FIG. 58A, of eccentric cam 206 presses against portionsof anvil half-section 114 while end portions, for example, 472 and 476of FIG. 58A, of eccentric cam 206 press against a portion of cartridgereceiving half-section 122 until the desired staple gap between theanvil half-section 114 and the cartridge half section 112 is achieved.Once it is achieved, eccentric cam 206 is fixedly secured in the throughholes 204. This feature will be discussed in greater detail below.

Turning now to FIGS. 41-49, an alternative embodiment of surgicalstapler 100 is depicted in which surgical stapler 100 includes acartridge receiving half-section clamp lever 112 a having a pair ofjuxtaposed mounting brackets 300 formed at a distal end thereof. Eachmounting bracket 300 is provided with an access slot 302 formed therein.Preferably, each access slot 302 is oriented or accessible substantiallyvertically (i.e., oriented substantially orthogonally with respect to alongitudinal axis of surgical stapler 100) when cartridge receivinghalf-section clamp lever 112 a is in an open position (as seen in FIGS.42 and 43). More preferably, each access slot is oriented to facemounting pins 304 when clamp lever 112 a is in the open position. Eachaccess slot 302 is configured and adapted to slidably receive a terminalend of a mounting pin 304 which extends and projects from the lateralsurfaces of anvil receiving half-section 114 a distance sufficient toengage each access slot 302 and has a cross-sectional dimension enablingit to be received within each access slot 302 (see FIGS. 45 and 46).

It is envisioned that each mounting bracket 300 can be provided with areinforcing member 306 (see FIGS. 42-44) extending across each accessslot 302 for strengthening, supporting and reinforcing the distal end ofeach access slot 302. Preferably, each reinforcing member 306 can beformed by stamping out an elongated slot in each mounting bracket 300and folding or doubling over a distal end of mounting bracket 300, overor across the elongated slot, to thereby provide an open distal end ofeach access slot 302 and to create reinforcing member 306.Alternatively, each reinforcing member 306 can be formed by terminatingeach mounting bracket 300 at a point along the access slot 302 andfixedly attaching a cross-bar across access slot 302, or by any othersuitable method known by those skilled in the art. Each access slot 302extends into and interconnects with a cam slot 308 also formed in eachmounting bracket 300.

Mounting of anvil half-section 114 to cartridge receiving half-section112 will now be described in connection with FIGS. 43, 44 and 47. Withcartridge receiving half-section clamp lever 112 a in an open position,anvil half-section 114 is united with cartridge receiving half-section112 by aligning each opposed mounting pin 304 with a respective accessslot 302 and advancing (i.e., moved forward, dropped-in, etc.) cartridgereceiving and anvil half-section 112, 114 toward one another untilmounting pins 304 are completely seated within access slots 302. Accessslots 302 ensure that half-sections 112, 114 are juxtaposed and inproper alignment with one another. Once mounting pin 304 is properly andcompletely seated within access slot 302, cartridge receivinghalf-section clamp lever 112 a is manipulated (i.e., pivoted) to aclosed position (as seen in FIGS. 44 and 47) whereby each end ofmounting pin 304 is advanced through cam slots 308 thereby closingsurgical stapler 100 as a result of the ramming action taking placetherebetween.

Preferably, when the anvil receiving half-section 114 is oriented in thehorizontal plane and the clamp lever 112 a is in the first position, theopening to each access slot 302 can be vertically accessed. It isenvisioned that each access channel 302 is generally orthogonal to thecartridge receiving half-section 112. As seen in FIG. 42, it is furtherenvisioned that each access channel 302 faces angularly relative to thecartridge receiving half-section 112. It is contemplated that eachaccess slot 302 can be generally L-shaped.

As seen throughout the figures the distal end of the anvil half-sectionspreferably taper downwardly in height from a proximal end portion towardthe distal end portion thereof. By way of example only, the proximal endportion of the anvil half-sections preferably have a height of about11.7 mm while the distal end portions of the anvil half-sectionspreferably have a height of about 10.2 mm, when the anvil half-sectionshave a length of about 100 mm.

In order to reinforce and strengthen the distal end of the anvilhalf-sections and to reduce a tendency of the distal end of the anvilhalf sections to deflect as a result of the stapling forces actingthereon, it is envisioned that at least one vertically orientedlongitudinally running reinforcing strip (not shown in the presentembodiment) is provided therewithin. The reinforcing strip is preferablymade of a substantially rigid non-flexible material, such as, forexample, stainless steel. It is contemplated that the reinforcing stripcan be either welded, crimped and/or snapped or otherwise friction fitinto place. It is further envisioned that the distal end of the anvilhalf-sections are provided with at least one transverse and/orlongitudinal reinforcing wall (not shown) in order to reduce thetendency of the distal end of the anvil half-sections from deforming dueto torsional forces.

Turning now to FIGS. 48 and 49, the proximal end of cartridge receivinghalf-section 112 is provided with a pair of juxtaposed pivot plates 310extending upwardly therefrom. Each pivot plate 310 is provided with apivot pin receiving slot 312 for receiving a pivot pin 314 (See FIG. 49)extending between and through a pair of end plates 315 located at aproximal end of anvil half-section 114. It is contemplated that areinforcing member 316 is provided between pivot plates 310 and isprovided with a slot 318 corresponding to pivot pin receiving slots 312.It is contemplated that reinforcing member 316 can be a separate memberor members secured between, or unitarily or integrally formed with pivotplates 310.

Turning now to FIGS. 50-102, another alternative embodiment of asurgical fastener applying apparatus is shown generally as 400.Apparatus 400 includes a cartridge receiving half-section 412, an anvilhalf-section 414 operatively coupled to cartridge receiving half-section412, a cartridge assembly 416 configured and adapted to be removablymounted within a distal end of cartridge receiving half-section 412 anda firing slide 410 configured and adapted to be slidably received withincartridge receiving half-section 412. As seen in FIGS. 51-53, and aswill be described in greater detail below, with cartridge receivinghalf-section clamping lever 430 in an open position, a proximal end ofanvil half-section 414 is slidably and pivotably receivable at aproximal end of cartridge receiving half-section 412. Mounting bosses554, projecting from anvil half-section 414, are slidably and pivotablyreceivable within an access channel 436 a of or defined by cartridgereceiving half-section clamping lever 430 in order to approximate adistal end of the cartridge receiving and anvil half-sections 412, 414.

Referring to FIGS. 56-65, and initially to FIGS. 56 and 57, anvilhalf-section 414 includes an anvil half-section channel member 460having a distal end 460 a and a proximal end 460 b. Channel member 460is substantially U-shaped and includes a pair of substantially parallelwall portions 462. Wall portions 462 preferably have a distal portion462 a having a height which is greater than a height of a proximalportion 462 b thereof. Wall portions 462 preferably are provided withapertures 464 formed preferably near or at a mid portion of channelmember 460, here shown as near the proximal end of distal portion 462 athereof, near the change in height from distal portion 462 a to proximalportion 462 b. Apertures 464 are configured and dimensioned to rotatablyreceive a gap adjustment cam 470 therein, as will be discussed ingreater detail below.

Anvil half-section 414 is provided with an anvil plate 544 configuredand dimensioned to be fit over wall portions 462 of distal portion 460 aof anvil half-section 414. Anvil plate 544 includes a pair of anvilsurfaces 546 having a plurality of anvil pockets 548 formed therein (seeFIG. 61). Preferably, anvil pockets 548 are arranged in two pairs oflongitudinal rows. Anvil plate 544 includes an anvil knife track 547formed longitudinally therealong. Anvil knife track 547 interconnectsand separates the pair of anvil surfaces 546 from one another. Anvilplate 544 includes a pair of upstanding side walls 549 extendingupwardly from outside edges of anvil surfaces 546 (see FIGS. 57 and 61).Accordingly, when anvil plate 544 is mounted to distal portion 460 a ofanvil half-section 414, side walls 549 of anvil plate 544 are preferablydisposed along the outside surface of distal wall portions 462 a (seeFIG. 61).

Anvil half-section 414 is further provided with a pair of longitudinallyrunning anvil reinforcing ribs 540 disposed between wall portions 462 ofdistal portion 460 a. It is envisioned that each reinforcing rib 540 iswelded, along an upper edge 540 a thereof, to a lower inside surface ofdistal portion 460 a of channel member 460. Reinforcing ribs 540 arepreferably welded within channel member 460 at a position such thatreinforcing ribs 540 are disposed on either side of anvil knife track547 (see FIG. 61). Reinforcing ribs 540 strengthen distal portion 460 aof anvil half-section 414 thus reducing the tendency for distal portion460 a to deflect as a result of the stapling forces acting thereon.Reinforcing ribs 540 preferably have a length substantially equal to alength of distal portion 460 a of anvil half-section 414. Each rib 540is provided with an aperture 542 formed near a proximal end thereof.Preferably, apertures 542 of ribs 540 are in axial and transverseregistration with apertures 464 formed in the distal portion 462 a ofwall portions 462.

Anvil half-section 414 includes a saddle element 550 fixedly securedthereon by welding, gluing, tacking, pinning or the like. Saddle element550 includes a body portion 552 having a pair of proximal legs 552 a anda pair of distal legs 552 b extending therefrom. Preferably, each distalleg 552 b includes a mounting boss 554 extending outwardly therefrom.Accordingly, when saddle element 550 is mounted onto anvil half-section414, mounting bosses 554 are disposed or extend and/or project outwardlyfrom the lateral surfaces of channel member 460. As will be described ingreater detail below, mounting bosses 554 assist in the proper andcomplete operative coupling of cartridge receiving half-section 412 withanvil half-section 414.

Anvil half-section 414 includes a gap adjustment cam 470, (see FIG. 58),operatively disposed in apertures 464 formed in wall portions 462 ofchannel member 460. A cam is herein understood to be a structure havinga periphery with at least two different points or areas along theperiphery, with each point or area having a different radius from therotational axis. Cams utilizable in accordance with the presentdisclosure can be any suitable shape (e.g., triangular, oblong, teardrop and the like).

As best seen in FIGS. 58, 58A and 58B, gap adjustment cam 470 preferablyincludes a cylindrical forward portion 472, cylindrical body portions474 and a cylindrical rearward portion 476. Cylindrical body portions474 of gap adjustment cam 470 have a central rotational axis “A” aboutwhich gap adjustment cam 470 rotates. Forward portion 472 and rearwardportion 476 preferably share a common axis “B”, spaced a distance “X”from central rotational axis “A” of body portions 474. Accordingly, asbody portions 474 rotate about central rotational axis “A”, forward andrearward portions 472, 476 act like cams to move one or more objectsplaced on or engaging forward and rearward portions 472, 476 through amaximum distance “2X”. While rotation of gap adjustment cam 470 resultsin a maximum distance of displacement of “2X” it is envisioned that gapadjustment cam 470 can be dimensioned to cause a displacement of anydistance upon full or partial rotation thereof.

While forward and rearward portions 472, 476 have been shown anddescribed as cylinders, it is envisioned that forward and rearwardportions 472, 476 can take on any other shape (e.g., an oval) whichcould define a camming surface and which other shape would determine thedistance “X” through which the one or more objects placed on or engagingforward and rearward portions 472, 476 would move. For example, if thecamming surface is not a cylinder, e.g., a teardrop shape, then theenlarged or cup portion of the teardrop shape would not be eccentric toaxis “A”.

As seen in FIGS. 58 and 58A, gap adjustment cam 470 includes a toothedannular channel 478 formed between body portions 474. Annular channel478 preferably has a common central axis which is aligned with centralaxis “A” of body portions 474. Preferably, annular channel 478 has adiameter which is less than a diameter of body portions 474 such thatteeth 480 of annular channel 478 lie below the surface of body portions474. Preferably, at least one of forward and rearward portions 472, 476is provided with a recess 482 formed in an end surface thereof. Recess482 is preferably configured and adapted to complementarily receive adistal end of a rotational tool (not shown) therein. Accordingly, gapadjustment cam 470 can be rotated by a rotation of a rotational toolwhich is operatively received within recess 482.

Referring again to FIG. 57 and as seen in greater detail in FIGS. 59 and61, forward portion 472 and rearward portion 476 of gap adjustment cam470 are configured and dimensioned to project outwardly from apertures464 formed in distal portion 462 a of wall portions 462 of channelmember 460. Preferably, body portion 474 of gap adjustment cam 470 isconfigured and dimensioned to be rotatably disposed within apertures464. Accordingly, as will be described in greater detail below as seenin FIGS. 54, 55, 64 and 65, when surgical fastener applying apparatus400 is assembled, forward portion 472 and rearward portion 476 of gapadjustment cam 470 rest atop a shoulder 421 of a respective hinge plate422 extending from cartridge receiving half-section 412. In this manner,as gap adjustment cam 470 is rotated about common central axis “A” ofbody portions 474, forward and rearward portions 472, 476 press againstshoulder 421 of hinge plate 422 as body portions 474 press against anupper surface of each aperture 464 formed in distal portion 462 a ofwall portions 462 thereby altering a relative spatial distance between adistal end portion of anvil half-section 414 and a distal end portion ofcartridge receiving half-section 412.

Gap adjustment cam 470 provides surgical fastener applying apparatus 400with a simple adjustment member whereby a spatial distance or gap “G”(see FIGS. 64 and 65), between a distal end of anvil half-section 414and a distal end of cartridge receiving half-section 412, can beadjusted and set to an accurate predetermined distance regardless of theincoming tolerances or variations resulting from the manufacturingand/or assembly process of the individual components of surgicalfastener applying apparatus 400. In other words, gap “G” can be set to anarrow tolerance due to the adjustability provided by gap adjustment cam470 irrespective of whether the individual components of surgicalfastener applying apparatus 400 are manufactured with a wide tolerance.

Gap “G” is measured between the upper face of the distal end portion ofcartridge receiving half-section 412 and the lower face of the distalend portion of anvil half-section 414, preferably with cartridgeassembly 416 and anvil plate 544 in place. By way of reference, thedistal end portion is considered that portion of cartridge receivinghalf-section 412 and anvil half-section 414 which is distal of the hingeplates and that encompasses or includes the working longitudinal extentor portion of cartridge receiving half-section 412 and anvilhalf-section 414.

As shown in FIG. 57, anvil half-section 414 includes a gap adjustmentcam lock 484. Gap adjustment cam lock 484 includes a body portion 486configured and adapted to be mounted to or otherwise secured betweenwall portions 462 of anvil half-section channel member 460 and a distalend portion 488 configured and adapted to engage teeth 480 of toothedannular channel 478 of gap adjustment cam 470. Preferably, gapadjustment cam 470, including teeth 480, is made from a hard metal, suchas, for example, stainless steel, while cam lock 484 is made from apliable material, such as, for example, plastic. Accordingly, when camlock 484 is pressed against teeth 480 of gap adjustment cam 470, teeth480 dig into distal end portion 488 of cam lock 484 and prevent furtherrotation of gap adjustment cam 470. Alternately, distal end portion 488includes at least one tooth 490 configured and dimensioned to snap-fitengage teeth 480 of toothed annular channel 478 of gap adjustment cam470. Accordingly, tooth 490 of distal end portion 488 of cam lock 484prevents gap adjustment cam 470 from freely rotating about commoncentral axis “A”. As such, gap adjustment cam 470 can be rotated to aplurality of discrete fixed positions corresponding to the positions ofteeth 480 of toothed annular channel 478. Moreover, a toothed cam lockallows gap adjustment cam 470 to be readjusted after the assembly ofsurgical fastener applying apparatus 400.

Referring back to FIG. 57, anvil half-section 414 includes a proximalend cap 492 configured and dimensioned to be received between a pair offlanges 494 provided at proximal end 460 b of anvil half-section 414(see FIGS. 59 and 60). A shaped pivot-limiting pin 496 is providedtherein which extends through elongated slots 498 formed in flanges 494and through a correspondingly shaped hole 500 formed through distal endcap 492. As will be described in greater detail below, shaped pivotlimiting pin 496 is substantially “pear or tear-drop shaped” and has abody portion 502, having a diameter, about which pin 496 rotates and aneccentric head portion 504, having a diameter less than the diameter ofbody portion 502, which extends radially outwardly from body portion 502and which, when in slots 498 and hole 500, limits the range of rotationof pin 496 about a central axis of body portion 502.

Anvil half-section 414 further includes a distal end cap 506 configuredand adapted to be snap-fit into the terminal end 509 of distal end 460 aof anvil half-section 414. Preferably, distal end cap 506 is tapered inshape in order to facilitate insertion of distal end 460 a of anvilhalf-section 414 into the target surgical site.

With reference to FIG. 56 and also particularly to FIGS. 66-86,cartridge receiving half-section 412 of surgical fastener applyingapparatus is shown and described. Cartridge receiving half-section 412includes a removable and disposable staple cartridge assembly 416.Staple cartridge assembly 416 includes a cartridge body 418, a pluralityof staple pushers attached to each other in groups of two offsetoriented pusher pairs 423, a bottom cover 422, a knife 424, having anangled sharpened leading edge 424 a and an atraumatic forward tip 424 c,a plurality of staples 426, a pivotably mounted safety lockout 428 and aremovable shipping wedge 431. As with known staple cartridge designs,cartridge body 418 has a plurality of rows of staple retaining slots 432formed therein. As seen in FIG. 67, in this embodiment, there are twostaggered rows of slots 432 formed on either side of a linear slottedtrack 434 which guides knife 424 during its longitudinal movement. Asingle staple 426 is positioned in each of slots 432.

As seen in FIG. 67, pusher pairs 423 are arranged in two series, oneseries on each side of slotted track 434, such that the center line ofpusher pairs 423 of each series of pusher pairs 423 forms a linecentered between the staggered rows of staples 426. The actuatingsurfaces of pusher pairs 423 act as cam followers and interact with apair of staggered camming surfaces 436 and 438 extending from a pair ofcam bars 440 (see FIGS. 56, 69-70) to expel the pairs of staples 426 oneach side of knife track 434. As illustrated, camming surfaces 436 and438 form a single angle relative to horizontal as each cam bar 440 ismoved distally. Cam bars 440 are moved distally until they are eitherstopped intentionally by the user to form less than all of staples 426,or until all of staples 426 are expelled from cartridge assembly 416.

As seen in FIG. 67, bottom cover 425 partially encloses the bottom of achannel formed by the upper surface and side walls of cartridge body418. A longitudinal ridge 425 a is formed on an upper surface of bottomcover 425 and serves as a bearing surface for knife bearing channel 442,which channel is secured to the bottom edge of knife 424, as knifetravels in knife track 434. Knife bearing channel 442 which ispreferably wider than knife track 434, is secured to the bottom surfaceof knife 424 such that knife bearing channel member 442 rides betweenknife track 434 and longitudinal ridge 425 a of bottom cover 425. Inthis manner, knife 424 is prevented from undergoing substantial verticalmovement during longitudinal translation in knife track 434.

As seen in FIGS. 67 and 68, safety lockout 428 is pivotably disposed onthe upper proximal end of cartridge body 418 and is movable from alocked orientation to an unlocked orientation. Preferably, safetylockout 428 is biased away from the locked orientation towards anorientation substantially perpendicular to the longitudinal axis ofcartridge body 418. Any suitable biasing member may be utilized such as,for example, spring 444. To overcome the bias towards the perpendicularorientation, safety lockout 428 includes an upper transverse horizontalsurface 428 a (see FIGS. 67, 68, 76, 88, 93 and 98-102) extending fromthe underside thereof which engages the undersurface of a hook 424 bformed on the upper edge surface of knife 424. This cooperativeengagement serves to retain safety lockout 428 in the locked orientationwhen safety lockout 428 covers knife 424.

When surgical stapler 400 has been unclamped, as will be described ingreater detail further herein, after either partial or complete firing,safety lockout 428 is biased to the perpendicular orientation (see FIGS.99-102), extending upwardly away from cartridge receiving half-section412. In this manner, safety lockout 428 prevents surgical stapler 400from being re-clamped until the partial or completely fired cartridgeassembly 416 is removed and replaced with a new cartridge assembly 416.

Similar to surgical stapler 100 of FIGS. 2-21, once surgical stapler 400has been at least partially fired, and if the instrument is opened,safety lockout 428 of cartridge assembly 416 automatically moves to theperpendicular orientation due to the spring bias mounting thereof. Withsafety lockout 428 in this orientation, surgical stapler 400 cannot bere-clamped in order to continue or to complete the firing. Thus, if theuser desires to apply further staples, the partially fired cartridgeassembly 416 must first be removed and replaced with a new or non-firedcartridge assembly 416.

As previously described with reference to surgical fastener applyingapparatus 100, shipping wedge 431 is removably attachable to cartridgebody 418 and is configured and dimensioned to cover the entire surfacearea of staple rows 426 and knife track 434.

Referring to FIG. 76, a loading and lockout mechanism 451 for cartridgeassembly 416 will now be described in detail. Loading and lockoutmechanism 451 facilitates loading of cartridge assembly 416 and preventsfiring of surgical stapler 400 until cartridge assembly 416 is properlyloaded on cartridge receiving half-section 412 and surgical stapler 400is properly clamped shut. Loading and lockout mechanism 451 includes arocker 452 which rests atop cartridge receiving half-section 412. Asseen in FIG. 76, rocker 452 preferably includes three slots, namely,open bottom slots 452 b, 452 c to permit longitudinal movement of cambar channel 440 of firing slide 410 and a closed central slot 452 d topermit passage of a knife actuating bar 454 therethrough.

Rocker 452 of surgical fastener applying apparatus functions in the samemanner as rocker 152 of surgical fastener applying apparatus 100. Rocker452 is biased, by way of a spring 456 which is disposed on transverselyextending post portions 452 a and between a ridge 452 f formed on a sideof the rocker 452 and an upper surface of cartridge receiving halfsection 412, downwardly toward a locked-out position. When in thelocked-out position, rocker 452 prevents cam bars 440 from distallongitudinal movement. In addition, when in the locked-out position, asseen in FIG. 88, a proximal edge surface 452 g of rocker 452 engages anotch 454 a formed in an upper edge of knife actuating bar 454 in orderto prevent distal longitudinal movement of knife actuating bar 454. Asbest shown in FIG. 88, rocker 452 is further provided with a downwardlyextending blocking surface 452 e which is in vertical alignment with anopening 440 a formed through the bottom surface of each cam bar 440 wheneach cam bar 440 is in its proximal-rest position

Upon joining anvil half-section 414 with cartridge receivinghalf-section 412, as seen in FIGS. 76, 87, 88 and 93, rocker 452 isurged to rotate as indicated by arrow “D” in FIG. 93 by the lowersurface of anvil half-section 414, and in particular cam lock 484,pressing against the upper surface of rocker 452. In this manner,proximal upper edge blocking surface 452 g is moved out of (i.e.,pivoted out of) engagement with notch 454 a of knife actuating bar 454thereby permitting a distal longitudinal movement of knife actuating bar454 through slot 452 d.

As seen in FIGS. 67 and 76, one of a pair of resilient friction fingers419 is provided on either side of cartridge body 418 near a proximal endthereof. Friction fingers 419 are configured and adapted to projectoutwardly from cartridge body 418 and to frictionally engage the innersurface of distal side walls 420 a (see FIG. 77) of cartridge receivinghalf-section channel member 420. In this manner, friction fingers 419prevent cartridge assembly 416 from falling out of cartridge receivinghalf-section 412.

As seen in FIGS. 56 and 69-71, firing slide 410 includes a pair ofcamming surfaces 436, 438 extending from a pair of cam bars 440 whichare joined to one another at a proximal end thereof, a knife actuatingbar 454 positioned between the pair of cam bars 440, a slide block 588operatively associated with the proximal end of the pair of cam bars440, and a firing lever 465 pivotably coupled to slide block 588. Firinglever 465 provides the user with the ability to fire surgical fastenerapplying apparatus 400 from either the left or the right side. As seenin FIG. 70 and in greater detail in FIG. 88, knife actuating bar 454includes a hook 454 a formed at a distal end thereof. Hook 454 a ofknife actuating bar 454 is configured and adapted to engage a hook 424 dformed at the proximal end of knife 424. In this manner, as knifeactuating bar 454 is displaced proximally and distally, so to is knife424.

Slide block 588 includes a hub 590 projecting therefrom and configuredand adapted to be snap-fit into a pivot hole 592 formed in lever 465.Slide block 588 further includes a pedal 594 reciprocally received witha hole 596 formed in slide block 588. As seen in FIG. 71, pedal 594includes a split body portion 594 a, configured and adapted to straddlea proximal end of knife actuating bar 454, and a pin 594 c extendingupwardly therefrom. Preferably, body portion 594 a includes an angleddistal surface 594 b. Preferably, pin 594 c is configured anddimensioned to extend completely through hole 596 of slide block 588. Asseen in FIG. 70, a compression spring 598 is disposed about pin 594 cand between split body portion 594 a of pedal 594 and slide block 588.In this manner, pedal 594 is biased away from slide block 588.

As seen in FIGS. 74 and 75, firing lever 465 includes an arcuate recess465 a formed in a bottom surface thereof. Arcuate recess 465 a definesthe range of rotation through which firing slide 465 can pivot about hub590 of slide block 588. Firing lever 465 further includes a stop recess465 b formed at each end of arcuate recess 465 a. As will be describedin greater detail below, stop recesses 465 b are configured anddimensioned to receive a distal end of pin 594 c of pedal 594 therein inorder to prevent firing lever 465 from pivoting about hub 590 during afiring stroke of surgical fastener applying apparatus 400.

Turning to FIGS. 56 and 76-86, cartridge receiving half-section 412 ofsurgical fastener applying apparatus 400 includes a cartridge receivinghalf-section channel member 420, a cartridge receiving half-sectionlever 430 pivotably coupled to channel 420, a cartridge lever releasemember 520 (see FIG. 85) operatively coupled to a proximal end ofcartridge lever 430, and a contoured cartridge lever cover 530configured and adapted to snap-fit over cartridge lever 430.

As seen in FIGS. 77 and 78, cartridge receiving half-section channelmember 420 includes a pair of juxtaposed hinge plates 422 extendingupwardly from the sides thereof. Preferably, hinge plates 422 are spaceda distance apart sufficient to permit anvil half-section channel member460 to be received therebetween. Turning momentarily back to FIG. 51,each hinge plate 422 includes a substantially U-shaped slot 424 formedthrough an upper edge thereof for permitting receipt of a respectivemounting nub or boss 554 of saddle element 550 therein. Each hinge plate422 further includes a shoulder 426 formed at a proximal end thereof.Shoulders 426 define a substantially planar horizontal surface 426 a onwhich forward and rearward portions 472, 476 of gap adjustment cam 470rests (see FIGS. 64 and 65).

A pivot bracket 428 is secured to a bottom surface of cartridgereceiving half-section channel member 420. Pivot bracket 428 includes anannular portion 428 a configured and adapted to receive a pivot pin 432therethrough (see FIG. 56).

Cartridge receiving half-section channel member 420 further includes apair of juxtaposed pivot plates 510 extending upwardly from a proximalend thereof. Each pivot plate 510 is provided with a pivot pin receivingslot 512 for receiving shaped pivot limiting pin 496 of anvilhalf-section 414 therein (see FIG. 52). As seen in FIG. 78, cartridgereceiving half-section channel member 420 further includes a cartridgelever latch 514 formed at a proximal end thereof.

Turning now to FIGS. 83 and 84, clamping lever 430 includes a bodyportion 434 having a pair of juxtaposed hinge plates 436 extendingupwardly from a distal end thereof and a pair of juxtaposed pinreceiving brackets 438 extending downwardly from a distal end thereof.Each pin receiving bracket 438 is provided with a pin receiving hole 438a formed therein for receiving the ends of pivot pin 432 (see FIG. 56)therein.

Each hinge plate 436 is provided with an access channel 436 a formedtherein. A portion of one channel cover for an access channel 436 a isshown broken away. Preferably, each access channel 436 a has a firstportion 436 b which is oriented substantially vertically when clampinglever 430 is in an open position (see FIG. 51) and a second portion 436c which is oriented substantially horizontally when clamping lever 430is being moved to and is in a closed position (see FIGS. 64 and 65).Each access channel 436 a is configured and adapted to slidably receivea respective mounting boss 554 of saddle 550 therein, which mountingbosses 554 extend and project from the lateral surface of anvilhalf-section channel member 460 a distance sufficient to engage eachaccess channel 436 a and have a cross-sectional dimension enabling it tobe received within each access channel 436 a. Preferably, accesschannels 436 a are covered in order to prevent tissue from being trappedwithin access channels 436 a and in order to provide additional strengthto each hinge plate 436.

As seen in FIGS. 56 and 81, cartridge lever release member 520 is springbiased proximally toward a lateral position via a spring member 522 andis provided with a catch 524 (see FIGS. 81 and 90) for engagingcartridge lever latch 514 (see FIG. 94) formed at the proximal end ofcartridge receiving half-section channel member 420. In order to releasecartridge lever latch 514, the user presses release member 520 in adistal direction, thereby disengaging catch 524 from latch 514.

In order to prevent inadvertent opening of clamping lever 430, as seenin FIGS. 81 and 85, release member 520 is provided with a projection 520a extending downwardly from a proximal end thereof, which projection 520a is seated within a guard 532 formed at a proximal end of cartridgelever cover 530.

Cartridge receiving half-section 412 is further provided with a leafspring 534 as seen in FIGS. 56 and 79, having a proximal end 534 asecured to an inside of clamping lever 430, via a post member 536, and afree distal end 534 b contacting a bottom surface of cartridge receivinghalf-section channel member 420. In this manner, clamping lever 430 isspring biased away from cartridge receiving half-section channel member420.

With reference to FIGS. 64-65 and 87-102, use and operation of surgicalfastener applying apparatus 400 is shown and described. Initially, withreference to FIGS. 64 and 65, after assembly of most, if not at all ofthe individual components of surgical fastener applying apparatus 400,gap “G” can be set (see FIG. 65). According to one method of setting gap“G”, a gauging element, such as, for example, a feeler gauge, (notshown) having a predetermined fixed thickness is inserted into gap “G”between the distal ends of cartridge receiving half-section 412 andanvil half-section 414, preferably between tissue contacting surfaces ofcartridge assembly 416 and of anvil 544. Gap adjustment cam 470 is fixedor rotated and fixed, causing cartridge receiving half-section 412and/or anvil half-section 414 to displace relative to one another, untilgap “G” is set to the predetermined thickness of the gauging element.Gap adjustment cam 470 is adjusted until cartridge receivinghalf-section 412 and anvil half-section 414 contact the gauging element.As seen in FIG. 65, rotation of gap adjustment cam 470, as indicated byarrow “C” results in rotation of, for example, anvil receivinghalf-section 414, about pivot point “Y” (i.e., mounting bosses 554), inthe direction indicated by arrow “C₁”. Accordingly, gap “G” will benarrower at the distal tip and will become progressively wider from thedistal tip towards hinge plates 422, such that in the loaded condition,with tissue present, deflection will occur at the tip to create a moreuniform gap along the overall distal portion of surgical fastenerapplying apparatus 400.

Once the position of gap adjustment cam 470 is fixed or set, gapadjustment cam 470 is fixedly held in position by cam lock 484 such thatfurther rotation of gap adjustment cam 470 is prevented. While theadjustment and the setting of gap “G” is a step which preferably takesplace during the manufacture and assembly of surgical fastener applyingapparatus 400, it is envisioned that the adjustment and setting of gap“G” can take place post manufacturing and assembly, including by a user,but preferably prior to packaging or use of the stapler. Other suitablemeans and methods for adjusting gap “G” can be employed at the same timeor other times during or as part of the manufacturing or assemblyprocess. It is envisioned that adjustment of the size of gap “G”, suchas, for example, during the manufacturing and assembly process, allowsfor the manufacture of surgical fastener applying apparatus which can beset to varying predetermined gap sizes in order to accommodate cartridgeassemblies having different length staples therein. In other words, if acartridge assembly having relatively shorter length staples is to beused, the gap can be set to a narrower dimension. Alternatively, if acartridge assembly having relatively longer length staples is to beused, the gap can be set to a larger dimension.

One method or sequence of coupling and closure of cartridge receivinghalf-section 412 with anvil half-section 414 is best seen in FIGS.87-91. With cartridge lever 430 in an open position, as seen in FIGS.51, 52 and 87, the proximal ends of half-section 412, 414 areapproximated toward one another such that pivot limiting pin 496 ofanvil half-section 414 rests within pivot pin receiving slots 512 ofpivot plates 510 of cartridge receiving half-section 412. As best seenin FIG. 91, the shape of pivot limiting pin 496 limits the longitudinalangle (i.e., the angle between cartridge receiving half-section 412 andanvil half-section 414) at which anvil half-section 414 can be coupledwith cartridge receiving half-section 412 to an angle “α”. Preferably,angle “α” is about 15°. With the proximal ends of half-section 412, 414coupled to one another, the distal ends of half-section 412, 414 areapproximated towards one another until mounting bosses 554, projectingfrom anvil half-section 414, are received within first portion 436 b ofaccess channels 436 a formed on clamping lever 430. Alternatively, thedistal ends or mid portions of half-sections 412, 414 can be coupled toone another before the proximal ends are joined to one another. It isalso further envisioned that the proximal and distal ends ofhalf-sections 412, 414 can be simultaneously coupled to one another.

With mounting bosses 554 positioned within access channels 436 a ofcartridge lever 430 (see FIGS. 51, 64 and 65), the proximal end ofclamping lever 430 is approximated toward cartridge receivinghalf-section 412 until catch 524 of release member 520 engages latch 514of cartridge receiving half-section channel member 420 (see FIG. 94). Byapproximating clamping lever 430 toward cartridge receiving half-section412, mounting bosses 554 are advanced through access channels 436 a(i.e., from first portion 436 b to second portion 436 c, as seen in FIG.64) thereby completing the approximation of cartridge receivinghalf-section 412 with anvil half-section 414, as a result of the cammingaction taking place therebetween.

As seen in FIGS. 92-94, complete approximation of half-sections 412, 414to one another results in the disengagement of rocker 452 from firingslide 410, including cam bar 440 and knife actuating bar 454, asevidenced by arrow “D” in FIG. 93. In particular, proximal edge surface452 g of rocker 452 disengages notch 454 a of knife actuating bar 454and blocking surface 452 e disengages opening 440 a formed in cam bar440. With rocker 452 disengaged from knife actuating bar 454 and cam bar440, the user is now able to fire surgical fastener applying apparatus400 by driving firing slide 410 distally.

Firing slide 410 is driven distally by advancing firing lever 465 in adistal direction, as indicated by arrow “E” of FIG. 95. As seen in FIGS.94 and 98, distal advancement of firing lever 465 results in pedal 594rising up due to the camming action of angled distal surface 594 b ofbody portion 594 a against cartridge receiving half-section channelmember 420. In so doing, the distal end of pin 594 c is received in astop recess 465 b (sec FIGS. 74 and 75) of firing lever 465 in order toprevent firing lever 465 from rotating about hub 590 of slide block 588.

As seen in FIGS. 93 and 98, distal advancement of firing slide 410 alsoresults in the disengagement of transverse horizontal surface 428 a ofsafety lockout 428 from hook 424 b formed on the upper edge surface ofknife 424. Accordingly, when surgical fastener applying apparatus 400 isunclamped, alter either partial or complete firing, safety lockout 428is biased to the perpendicular orientation (see FIGS. 99-102), extendingupwardly away from cartridge receiving half-section 412. In this manner,safety lockout 428 prevents surgical fastener applying apparatus 400from being re-clamped until partial or completely fired cartridgeassembly 416 is removed and replaced with a new cartridge assembly 416.

It is envisioned that any of the surgical fastener applying apparatusdisclosed herein can be configured and adapted to receive a staplecartridge loaded with a plurality of directionally biased staples and/orspecially configured axial pockets as disclosed in commonly assignedU.S. patent application Ser. No. 09/972,594, filed Oct. 5, 2001 which isa Continuation-in-Part application of U.S. Ser. No. 09/693,379, fieldOct. 20, 2000, both of which are entitled “Directionally Biased Stapleand Method of Manufacture”, the entire contents of each of which areincorporated herein by reference.

It will be understood that various modifications may be made to theembodiments of the surgical fastener applying apparatus disclosedherein. Therefore, the above description should not be construed aslimiting, but merely as exemplifications of preferred embodiments. Thoseskilled in the art will envision other modifications within the scopeand spirit of the present disclosure.

1-32. (canceled)
 33. A surgical stapling apparatus, comprising: acartridge half-section; a replaceable staple cartridge assemblyselectively receivable in the cartridge half-section, the replaceablestaple cartridge assembly including: a cartridge body with stapleretaining slots; a plurality of surgical staples disposed within thestaple retaining slots of the cartridge body; a plurality of staplepusher members; and a knife having a coupling member disposed at aproximal end of the knife; an anvil half-section having an anvil surfacefor forming the plurality of surgical staples deployed from thecartridge half-section; and a knife drive member secured to at least oneof the cartridge half-section and the anvil half-section, the knifedrive member having a knife coupling feature disposed at a distal end ofthe knife drive member, the coupling member of the knife beingconfigured to engage the knife coupling feature of the knife drivemember such that reciprocal axial movement of the knife drive membermoves the knife between extended and retracted positions within thestaple cartridge assembly.
 34. The surgical stapling apparatus of claim33, further comprising a firing lever secured to at least one of theanvil half-section and the cartridge half-section, the firing leverbeing longitudinally movable to sequentially fire the plurality ofsurgical staples, wherein the firing lever is pivotable to extend from aselected one of a right and left side of the apparatus.
 35. The surgicalstapling apparatus of claim 33, wherein the knife includes a sharpeneddistal end and an atraumatic tip extending forwardly of the sharpeneddistal end.
 36. The surgical stapling apparatus of claim 33, wherein thecoupling member of the knife forms a first hook and the knife couplingfeature of the knife drive member forms a second hook, wherein the firstand second hooks are interconnected.
 37. The surgical stapling apparatusof claim 33, further comprising a first clamp lever operativelyconnected to the cartridge half-section and a second clamp leveroperatively connected to the anvil half-section, at least one of theclamp levers being movable from a closed position in which the cartridgehalf-section and the anvil half-section are in a clamped position to anopen position in which the cartridge half-section and the anvilhalf-section are in an unclamped position.
 38. The surgical staplingapparatus of claim 37, wherein the replaceable staple cartridge assemblyincludes a safety lockout secured to the cartridge body that preventsreclamping of the cartridge half-section and the anvil half-sectionuntil a partially or completely fired staple cartridge assembly isremoved and replaced with an unfired cartridge assembly.
 39. Thesurgical stapling apparatus of claim 33, wherein the cartridge body ofthe cartridge half-section includes a pair of upstanding posts, theknife being disposed between the upstanding posts when the knife drivemember maintains the knife in the retracted position.
 40. A replaceablestaple cartridge assembly for use with a surgical stapling apparatusincluding a cartridge half-section, an anvil half-section, and a knifedrive member having a knife coupling feature disposed at a distal end ofthe knife drive member, the cartridge assembly, comprising: a cartridgebody supporting a plurality of surgical staples, a plurality of staplepusher members, and a knife; the knife including a sharpened distal endand a knife body extending from the sharpened distal end, the knife bodyincluding a coupling member disposed at a proximal end of the knifebody, the coupling member configured to receive the knife couplingfeature of the knife drive member of the surgical stapling apparatuswhen the cartridge body is secured to the surgical stapling apparatus.41. The replaceable staple cartridge assembly of claim 40, wherein theknife includes a sharpened distal end and an atraumatic tip extendingforwardly of the sharpened distal end.
 42. The replaceable staplecartridge assembly of claim 40, wherein the coupling member of the knifeforms a hook.
 43. The replaceable staple cartridge assembly of claim 40,further comprising a safety lockout secured to the cartridge body thatis movable to a locking position when the cartridge assembly is at leastpartially fired.
 44. A replaceable staple cartridge assembly,comprising: a cartridge body having a proximal end and a distal end, thecartridge body supporting a plurality of surgical staples, a pluralityof staple pusher members, and a knife; the entire knife being disposeddistally of the proximal end of the cartridge body, the knife beingaxially movable along the cartridge body between a proximal position anda distal position, the knife including a sharpened distal end and aknife body extending from the sharpened distal end, the knife bodyincluding a coupling member at a proximal end of the knife body, thecoupling member configured to couple to a knife drive member of asurgical stapling apparatus.
 45. The replaceable staple cartridgeassembly of claim 44, wherein the knife includes a sharpened distal endand an atraumatic tip extending forwardly of the sharpened distal end.46. The replaceable staple cartridge assembly of claim 44, wherein thecoupling member of the knife forms a hook.
 47. The replaceable staplecartridge assembly of claim 44, further comprising a safety lockoutsecured to the cartridge body that is movable to a locking position whenthe cartridge assembly is at least partially fired.